{ "name": "U.S. Testosterone Recall Register, 2024–2026", "version": "2026-09-03", "verified_date": "2026-09-03", "source_export_date": "2026-08-27", "source_export_url": "https://download.open.fda.gov/drug/enforcement/drug-enforcement-0001-of-0001.json.zip", "source_manifest_url": "https://api.fda.gov/download.json", "page_url": "https://trtproviderguide.com/research/testosterone-recall/", "methodology_url": "https://trtproviderguide.com/research/data/testosterone-recall-methodology.md", "scope": { "start_date": "2024-01-01", "end_date": "2026-08-27", "rule": "Include a unique FDA human-drug enforcement record when recall_initiation_date is 2024-01-01 or later and the FDA product description names testosterone or a testosterone-containing combination as the recalled medicine." }, "record_count": 45, "event_id_count": 11, "distinct_recalling_firm_count": 9, "notes": [ "A record is one FDA recall number.", "Related records are grouped by FDA event_id.", "FDA event 98344 has 25 product records in all; this dataset includes its 16 testosterone-containing rows and excludes 9 estradiol rows.", "Product summaries, dosage-form labels, issue groups, and event labels are editorial fields; the FDA reason_for_recall text is preserved separately.", "Pellets, vials, cartons, and packets are not added into one total.", "Calculated quantities appear only when the FDA package description gives an explicit multiplier.", "FDA record D-0129-2026 contains the incomplete expiration string /9/2026; it is preserved without guessing." ], "records": [ { "recall_number": "D-0331-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 100 mg / anastrozole 4 mg sterile pellet", "ndc": "79559-4104-32", "lot_and_expiration": "254000105 (exp. 2026-05-28); 254000110 (exp. 2026-08-07); 254000112 and 254000113 (exp. 2026-09-26)", "reported_quantity": "1,464 pellets", "reported_quantity_value": 1464, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0331-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0330-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 87.5 mg / triamcinolone acetonide 17.5 mcg sterile pellet", "ndc": "79559-6087-32", "lot_and_expiration": "256000103 (exp. 2026-07-28)", "reported_quantity": "1,631 pellets", "reported_quantity_value": 1631, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0330-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0329-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 200 mg / triamcinolone acetonide 40 mcg sterile pellet", "ndc": "79559-6200-43", "lot_and_expiration": "256000105 (exp. 2026-09-19)", "reported_quantity": "7,840 pellets", "reported_quantity_value": 7840, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0329-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0328-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 100 mg / triamcinolone acetonide 20 mcg sterile pellet", "ndc": "79559-6100-32", "lot_and_expiration": "256000104 (exp. 2026-07-30)", "reported_quantity": "4,599 pellets", "reported_quantity_value": 4599, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0328-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0327-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 75 mg / anastrozole 4 mg sterile pellet", "ndc": "79559-4079-32", "lot_and_expiration": "254000107 (exp. 2026-06-30); 254000111 (exp. 2026-08-07)", "reported_quantity": "670 pellets", "reported_quantity_value": 670, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0327-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0326-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 100 mg / anastrozole 4 mg sterile pellet", "ndc": "79559-4104-01", "lot_and_expiration": "254000104 (exp. 2026-05-27)", "reported_quantity": "100 pellets", "reported_quantity_value": 100, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0326-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0325-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 303 mg sterile pellet", "ndc": "79559-1303-01", "lot_and_expiration": "251000124 (exp. 2026-06-02)", "reported_quantity": "1,015 pellets", "reported_quantity_value": 1015, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0325-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0324-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 200 mg sterile pellet", "ndc": "79559-1200-43", "lot_and_expiration": "251000127 (exp. 2026-06-03); 251000128 (exp. 2026-06-05); 251000133, 251000134 and 251000135 (exp. 2026-06-16); 251000138, 251000139, 251000140 and 251000141 (exp. 2026-06-25); 251000147, 251000148 and 251000149 (exp. 2026-07-28); 251000156 and 251000157 (exp. 2026-08-08); 251000164, 251000165 and 251000166 (exp. 2026-08-22); 251000169 (exp. 2026-08-29); 251000171 and 251000172 (exp. 2026-09-03); 251000180 (exp. 2026-09-19)", "reported_quantity": "194,336 pellets", "reported_quantity_value": 194336, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0324-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0323-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 100 mg sterile pellet", "ndc": "79559-1100-32", "lot_and_expiration": "251000132 (exp. 2026-06-16); 251000142 (exp. 2026-06-30); 251000144 (exp. 2026-07-14); 251000146 (exp. 2026-07-21); 251000162 and 251000163 (exp. 2026-08-16); 251000167 (exp. 2026-08-22); 251000177 (exp. 2026-09-12)", "reported_quantity": "153,498 pellets", "reported_quantity_value": 153498, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0323-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0322-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 87.5 mg sterile pellet", "ndc": "79559-1087-32", "lot_and_expiration": "251000145 (exp. 2026-07-14); 251000161 (exp. 2026-08-16); 251000175 (exp. 2026-09-08)", "reported_quantity": "62,581 pellets", "reported_quantity_value": 62581, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0322-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0321-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 62.5 mg sterile pellet", "ndc": "79559-1062-32", "lot_and_expiration": "251000125 (exp. 2026-06-02)", "reported_quantity": "1,758 pellets", "reported_quantity_value": 1758, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0321-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0320-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 50 mg sterile pellet", "ndc": "79559-1050-32", "lot_and_expiration": "251000122 (exp. 2026-04-01); 251000151 (exp. 2026-08-02); 251000155 (exp. 2026-08-08); 251000173 (exp. 2026-09-05)", "reported_quantity": "70,959 pellets", "reported_quantity_value": 70959, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0320-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0319-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 37.5 mg sterile pellet", "ndc": "79559-1037-32", "lot_and_expiration": "251000131 (exp. 2026-06-16); 251000136 (exp. 2026-08-02); 251000150 (exp. 2026-08-12); 251000158 (exp. 2026-08-14); 251000159 (exp. 2026-06-16)", "reported_quantity": "60,868 pellets", "reported_quantity_value": 60868, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0319-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0318-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 25 mg sterile pellet", "ndc": "79559-1025-32", "lot_and_expiration": "251000130 (exp. 2026-06-02); 251000137 (exp. 2026-06-19); 251000152 (exp. 2026-08-02); 251000168 (exp. 2026-08-29); 251000170 (exp. 2026-09-03)", "reported_quantity": "89,074 pellets", "reported_quantity_value": 89074, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0318-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0317-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 18 mg sterile pellet", "ndc": "79559-1018-32", "lot_and_expiration": "251000126 (exp. 2026-06-03)", "reported_quantity": "146 pellets", "reported_quantity_value": 146, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0317-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0316-2026", "event_id": "98344", "event_label": "Asteria Health pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:98344&limit=100", "recall_initiation_date": "2026-01-26", "recalling_firm": "F.H. Investments, Inc. (dba Asteria Health)", "form": "Pellet", "product_summary": "Testosterone 12.5 mg sterile pellet", "ndc": "79559-1012-32", "lot_and_expiration": "251000143 (exp. 2026-07-07); 251000160 (exp. 2026-08-16)", "reported_quantity": "3,871 pellets", "reported_quantity_value": 3871, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "Presence of Foreign substance - potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0316-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0198-2026", "event_id": "97944", "event_label": "Teva 1% gel packet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97944&limit=100", "recall_initiation_date": "2025-11-07", "recalling_firm": "Teva Pharmaceuticals USA, Inc.", "form": "Gel", "product_summary": "Testosterone gel 1%, 2.5 g per unit-dose packet, 30 packets per carton", "ndc": "0591-3216-30 (carton); 0591-3216-17 (packet)", "lot_and_expiration": "100068692 (exp. 2027-04-30)", "reported_quantity": "15,944 cartons (478,320 packets calculated)", "reported_quantity_value": 15944, "reported_quantity_unit": "cartons", "calculated_quantity_value": 478320, "calculated_quantity_unit": "packets", "fda_classification": "Class III", "issue_group": "Leaking packet seal", "fda_reason_for_recall": "Defective Container - A defect in the side-seal which allows leakage of product.", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0198-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0137-2026", "event_id": "97799", "event_label": "Farmakeio pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97799&limit=100", "recall_initiation_date": "2025-10-14", "recalling_firm": "Farmakeio Outsourcing, LLC", "form": "Pellet", "product_summary": "Testosterone 200 mg / triamcinolone acetonide 40 mcg sterile pellet", "ndc": "73693-0364-01", "lot_and_expiration": "3075 (exp. 2026-01-02); 3084 (exp. 2026-01-06); 3110 (exp. 2026-01-15); 3115 (exp. 2026-01-16); 3116 (exp. 2026-01-20); 3119 (exp. 2026-01-21); 3121 (exp. 2026-01-22); 3124 (exp. 2026-01-23); 3125 (exp. 2026-01-28); 3131 (exp. 2026-01-29); 3134 (exp. 2026-02-03); 3135 (exp. 2026-02-04); 3139 (exp. 2026-02-06); 3204 (exp. 2026-02-13); 3205 (exp. 2026-02-18); 3207 (exp. 2026-02-19); 3208 (exp. 2026-02-24); 3211 (exp. 2026-02-25); 3213 (exp. 2026-02-26); 3216 (exp. 2026-02-27); 3223 (exp. 2026-03-04); 3225 (exp. 2026-03-05); 3228 (exp. 2026-03-06); 3248 (exp. 2026-03-19); 3254 (exp. 2026-03-25); 3258 (exp. 2026-03-31); 3269 (exp. 2026-04-01); 3270 (exp. 2026-04-10)", "reported_quantity": "264,664 pellets", "reported_quantity_value": 264664, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "CGMP Deviations: Potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0137-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0136-2026", "event_id": "97799", "event_label": "Farmakeio pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97799&limit=100", "recall_initiation_date": "2025-10-14", "recalling_firm": "Farmakeio Outsourcing, LLC", "form": "Pellet", "product_summary": "Testosterone 100 mg / triamcinolone acetonide 20 mcg sterile pellet", "ndc": "73693-0367-01", "lot_and_expiration": "3098 and 3101 (exp. 2026-01-08); 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"2025-10-14", "recalling_firm": "Farmakeio Outsourcing, LLC", "form": "Pellet", "product_summary": "Testosterone 62.5 mg / triamcinolone acetonide 12.5 mcg sterile pellet", "ndc": "73693-0366-01", "lot_and_expiration": "3090 (exp. 2026-01-07); 3181 (exp. 2026-02-11); 3189 and 3190 (exp. 2026-02-12)", "reported_quantity": "31,124 pellets", "reported_quantity_value": 31124, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "CGMP Deviations: Potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0134-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0133-2026", "event_id": "97799", "event_label": "Farmakeio pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97799&limit=100", "recall_initiation_date": "2025-10-14", "recalling_firm": "Farmakeio Outsourcing, LLC", "form": "Pellet", "product_summary": "Testosterone 50 mg / triamcinolone acetonide 10 mcg sterile pellet", "ndc": "73693-0365-01", "lot_and_expiration": "3091, 3096 and 3097 (exp. 2026-01-07); 3182, 3186, 3187 and 3188 (exp. 2026-02-10)", "reported_quantity": "64,924 pellets", "reported_quantity_value": 64924, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "CGMP Deviations: Potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0133-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0132-2026", "event_id": "97799", "event_label": "Farmakeio pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97799&limit=100", "recall_initiation_date": "2025-10-14", "recalling_firm": "Farmakeio Outsourcing, LLC", "form": "Pellet", "product_summary": "Testosterone 37.5 mg / triamcinolone acetonide 7.5 mcg sterile pellet", "ndc": "73693-0380-01", "lot_and_expiration": "3143 (exp. 2026-02-05); 3160 and 3161 (exp. 2026-02-11); 3165 and 3166 (exp. 2026-02-12)", "reported_quantity": "43,424 pellets", "reported_quantity_value": 43424, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "CGMP Deviations: Potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0132-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0131-2026", "event_id": "97799", "event_label": "Farmakeio pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97799&limit=100", "recall_initiation_date": "2025-10-14", "recalling_firm": "Farmakeio Outsourcing, LLC", "form": "Pellet", "product_summary": "Testosterone 25 mg / triamcinolone acetonide 5 mcg sterile pellet", "ndc": "73693-0379-01", "lot_and_expiration": "3148, 3154 and 3155 (exp. 2026-02-05); 3162 (exp. 2026-02-11); 3167 (exp. 2026-02-12)", "reported_quantity": "36,924 pellets", "reported_quantity_value": 36924, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "CGMP Deviations: Potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0131-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0130-2026", "event_id": "97799", "event_label": "Farmakeio pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97799&limit=100", "recall_initiation_date": "2025-10-14", "recalling_firm": "Farmakeio Outsourcing, LLC", "form": "Pellet", "product_summary": "Testosterone 12.5 mg / triamcinolone acetonide 2.5 mcg sterile pellet", "ndc": "73693-0363-01", "lot_and_expiration": "3171 and 3172 (exp. 2026-02-11)", "reported_quantity": "18,124 pellets", "reported_quantity_value": 18124, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "CGMP Deviations: Potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0130-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0129-2026", "event_id": "97799", "event_label": "Farmakeio pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97799&limit=100", "recall_initiation_date": "2025-10-14", "recalling_firm": "Farmakeio Outsourcing, LLC", "form": "Pellet", "product_summary": "Testosterone regular-release 200 mg sterile pellet", "ndc": "73693-0402-01", "lot_and_expiration": "3201 (exp. 2026-02-07); 3202 (exp. 2026-02-21); 3280 (exp. 2026-04-08); 3283 (FDA source shows an incomplete expiry: /9/2026)", "reported_quantity": "14,329 pellets", "reported_quantity_value": 14329, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "CGMP Deviations: Potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0129-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0128-2026", "event_id": "97799", "event_label": "Farmakeio pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97799&limit=100", "recall_initiation_date": "2025-10-14", "recalling_firm": "Farmakeio Outsourcing, LLC", "form": "Pellet", "product_summary": "Testosterone regular-release 50 mg sterile pellet", "ndc": "73693-0401-01", "lot_and_expiration": "3178 (exp. 2026-02-07)", "reported_quantity": "4,829 pellets", "reported_quantity_value": 4829, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "CGMP Deviations: Potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0128-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0127-2026", "event_id": "97799", "event_label": "Farmakeio pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97799&limit=100", "recall_initiation_date": "2025-10-14", "recalling_firm": "Farmakeio Outsourcing, LLC", "form": "Pellet", "product_summary": "Testosterone 200 mg sterile pellet", "ndc": "73693-0381-01", "lot_and_expiration": "3203 (exp. 2026-02-17); 3284 (exp. 2026-04-08)", "reported_quantity": "4,929 pellets", "reported_quantity_value": 4929, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "CGMP Deviations: Potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0127-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0126-2026", "event_id": "97799", "event_label": "Farmakeio pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97799&limit=100", "recall_initiation_date": "2025-10-14", "recalling_firm": "Farmakeio Outsourcing, LLC", "form": "Pellet", "product_summary": "Testosterone 87.5 mg sterile pellet", "ndc": "73693-0386-01", "lot_and_expiration": "3193 (exp. 2026-02-17)", "reported_quantity": "529 pellets", "reported_quantity_value": 529, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "CGMP Deviations: Potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0126-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0125-2026", "event_id": "97799", "event_label": "Farmakeio pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97799&limit=100", "recall_initiation_date": "2025-10-14", "recalling_firm": "Farmakeio Outsourcing, LLC", "form": "Pellet", "product_summary": "Testosterone 62.5 mg sterile pellet", "ndc": "73693-0383-01", "lot_and_expiration": "3180 (exp. 2026-02-17)", "reported_quantity": "829 pellets", "reported_quantity_value": 829, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "CGMP Deviations: Potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0125-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0124-2026", "event_id": "97799", "event_label": "Farmakeio pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97799&limit=100", "recall_initiation_date": "2025-10-14", "recalling_firm": "Farmakeio Outsourcing, LLC", "form": "Pellet", "product_summary": "Testosterone 50 mg sterile pellet", "ndc": "73693-0387-01", "lot_and_expiration": "3179 (exp. 2026-02-17)", "reported_quantity": "829 pellets", "reported_quantity_value": 829, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "CGMP Deviations: Potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0124-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0123-2026", "event_id": "97799", "event_label": "Farmakeio pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97799&limit=100", "recall_initiation_date": "2025-10-14", "recalling_firm": "Farmakeio Outsourcing, LLC", "form": "Pellet", "product_summary": "Testosterone 25 mg sterile pellet", "ndc": "73693-0389-01", "lot_and_expiration": "3294 (exp. 2026-04-08)", "reported_quantity": "1,329 pellets", "reported_quantity_value": 1329, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Possible metal particles", "fda_reason_for_recall": "CGMP Deviations: Potential presence of metal particulate matter", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0123-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0258-2026", "event_id": "97821", "event_label": "TESTO-100 pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97821&limit=100", "recall_initiation_date": "2025-10-03", "recalling_firm": "Advanced Pharmaceutical Technology, Inc.", "form": "Pellet", "product_summary": "TESTO-100 testosterone 100 mg, 10 sterile pellets per carton", "ndc": "57377-100-01", "lot_and_expiration": "P-22-3 (exp. 2027-06)", "reported_quantity": "22,843 pellets", "reported_quantity_value": 22843, "reported_quantity_unit": "pellets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Sterility or possible microbial contamination", "fda_reason_for_recall": "Lack of Assurance of Sterility: Potential microbial contamination of subcutaneous pellets.", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0258-2026%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0517-2025", "event_id": "97086", "event_label": "Qualgen pellet label recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:97086&limit=100", "recall_initiation_date": "2025-06-16", "recalling_firm": "Qualgen, LLC", "form": "Pellet", "product_summary": "Compounded testosterone 200 mg pellet in 1 mL amber vial", "ndc": "69761-202-01", "lot_and_expiration": "1043 (exp. 2026-02-10) — FDA says labels carried incorrect lot numbers; confirm with the firm or pharmacy", "reported_quantity": "2,832 amber vials", "reported_quantity_value": 2832, "reported_quantity_unit": "vials", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class III", "issue_group": "Incorrect lot labels", "fda_reason_for_recall": "Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot numbers on the label.", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0517-2025%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0531-2025", "event_id": "96981", "event_label": "TESTO-200 injection recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:96981&limit=100", "recall_initiation_date": "2025-05-30", "recalling_firm": "Advanced Pharmaceutical Technology, Inc.", "form": "Injection", "product_summary": "TESTO-200 testosterone cypionate injection 200 mg/mL, 10 mL multidose vial", "ndc": "57377-200-01", "lot_and_expiration": "P-24-1 (exp. 2027-02-28)", "reported_quantity": "26 vials", "reported_quantity_value": 26, "reported_quantity_unit": "vials", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Marketed without an approved FDA drug application", "fda_reason_for_recall": "Marketed Without an Approved NDA/ANDA", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0531-2025%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0420-2025", "event_id": "96808", "event_label": "Empower testosterone cypionate recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:96808&limit=100", "recall_initiation_date": "2025-05-02", "recalling_firm": "Empower Clinic Services, LLC dba Empower Pharmacy", "form": "Injection", "product_summary": "Compounded testosterone cypionate injection 200 mg/mL, 5 mL multidose vial", "ndc": "Not listed in FDA product description", "lot_and_expiration": "202364; compounded 2024-08-20; beyond-use date 2025-05-28", "reported_quantity": "8,230 vials", "reported_quantity_value": 8230, "reported_quantity_unit": "vials", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Sterility or possible microbial contamination", "fda_reason_for_recall": "Lack of Assurance of Sterility", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0420-2025%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0416-2025", "event_id": "96792", "event_label": "Belmar Select pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:96792&limit=100", "recall_initiation_date": "2025-04-28", "recalling_firm": "BSO, LLC dba Belmar Select Outsourcing", "form": "Pellet", "product_summary": "Testosterone pellet 200 mg blunt", "ndc": "70168-0121-01", "lot_and_expiration": "20250129@1 (exp. 2026-01-17); 20250218@4 (exp. 2026-01-25)", "reported_quantity": "1,964 vials", "reported_quantity_value": 1964, "reported_quantity_unit": "vials", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Glass particles", "fda_reason_for_recall": "Presence of Particulate Matter: Glass particles were found in pellet vials.", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0416-2025%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0415-2025", "event_id": "96792", "event_label": "Belmar Select pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:96792&limit=100", "recall_initiation_date": "2025-04-28", "recalling_firm": "BSO, LLC dba Belmar Select Outsourcing", "form": "Pellet", "product_summary": "Testosterone pellet 200 mg, cholesterol ≤4%", "ndc": "70168-0122-01", "lot_and_expiration": "20250205@6 (exp. 2026-01-30)", "reported_quantity": "1,447 vials", "reported_quantity_value": 1447, "reported_quantity_unit": "vials", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Glass particles", "fda_reason_for_recall": "Presence of Particulate Matter: Glass particles were found in pellet vials.", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0415-2025%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0414-2025", "event_id": "96792", "event_label": "Belmar Select pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:96792&limit=100", "recall_initiation_date": "2025-04-28", "recalling_firm": "BSO, LLC dba Belmar Select Outsourcing", "form": "Pellet", "product_summary": "Testosterone pellet 200 mg blunt, cholesterol ≤2%", "ndc": "70168-0124-01", "lot_and_expiration": "20250217@7 (exp. 2026-01-31)", "reported_quantity": "355 vials", "reported_quantity_value": 355, "reported_quantity_unit": "vials", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Glass particles", "fda_reason_for_recall": "Presence of Particulate Matter: Glass particles were found in pellet vials.", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0414-2025%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0413-2025", "event_id": "96792", "event_label": "Belmar Select pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:96792&limit=100", "recall_initiation_date": "2025-04-28", "recalling_firm": "BSO, LLC dba Belmar Select Outsourcing", "form": "Pellet", "product_summary": "Testosterone pellet 200 mg, cholesterol ≤2%", "ndc": "70168-0125-01", "lot_and_expiration": "20250207@1 (exp. 2026-01-31); 20250228@1 (exp. 2026-01-31)", "reported_quantity": "1,974 vials", "reported_quantity_value": 1974, "reported_quantity_unit": "vials", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Glass particles", "fda_reason_for_recall": "Presence of Particulate Matter: Glass particles were found in pellet vials.", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0413-2025%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0412-2025", "event_id": "96792", "event_label": "Belmar Select pellet recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:96792&limit=100", "recall_initiation_date": "2025-04-28", "recalling_firm": "BSO, LLC dba Belmar Select Outsourcing", "form": "Pellet", "product_summary": "Testosterone pellet 100 mg, cholesterol ≤4%", "ndc": "70168-0101-01", "lot_and_expiration": "20250102@6 (exp. 2025-12-11); 20250130@4 (exp. 2026-01-22)", "reported_quantity": "2,762 vials", "reported_quantity_value": 2762, "reported_quantity_unit": "vials", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Glass particles", "fda_reason_for_recall": "Presence of Particulate Matter: Glass particles were found in pellet vials.", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0412-2025%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0363-2025", "event_id": "96680", "event_label": "Eugia testosterone cypionate recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:96680&limit=100", "recall_initiation_date": "2025-04-10", "recalling_firm": "Eugia US LLC", "form": "Injection", "product_summary": "Testosterone cypionate injection USP 200 mg/mL, 1 mL single-dose vial", "ndc": "55150-277-01", "lot_and_expiration": "1TC24075A (exp. 2026-11-30)", "reported_quantity": "36,816 vials", "reported_quantity_value": 36816, "reported_quantity_unit": "vials", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Crystals that did not redissolve", "fda_reason_for_recall": "cGMP: complaints of crystals not redissolving into solution after warming and shaking the vials.", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0363-2025%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0294-2025", "event_id": "96412", "event_label": "Strides testosterone gel recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:96412&limit=100", "recall_initiation_date": "2025-03-05", "recalling_firm": "Strides Pharma Science Limited", "form": "Gel", "product_summary": "Testosterone gel 1%, 5 g packets, 30 unit-dose packets per carton", "ndc": "64380-152-02", "lot_and_expiration": "5501103A (exp. 2025-03); 5501237A and 5501238A (exp. 2025-04); 5501278A (exp. 2025-05); 5501280A and 5501342A (exp. 2025-06); 5501372A (exp. 2025-07); 5501496A (exp. 2025-08); 5501499A (exp. 2025-09); 5501580A (exp. 2025-10); 5501582A (exp. 2025-12); 5501653A and 5501656A (exp. 2026-01); 5501770A (exp. 2026-02); 5501842A, 5501868A and 5501882A (exp. 2026-04); 5501957A (exp. 2026-05); 5502001A (exp. 2026-07); 5502033A (exp. 2026-08); 5502112A and 5502115A (exp. 2026-10); 5502180A and 5502181A (exp. 2026-11)", "reported_quantity": "244,412 cartons (7,332,360 packets calculated)", "reported_quantity_value": 244412, "reported_quantity_unit": "cartons", "calculated_quantity_value": 7332360, "calculated_quantity_unit": "packets", "fda_classification": "Class II", "issue_group": "Benzene", "fda_reason_for_recall": "Presence of foreign substance: Presence of Benzene.", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0294-2025%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0293-2025", "event_id": "96412", "event_label": "Strides testosterone gel recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:96412&limit=100", "recall_initiation_date": "2025-03-05", "recalling_firm": "Strides Pharma Science Limited", "form": "Gel", "product_summary": "Testosterone gel 1%, 2.5 g packets, 30 unit-dose packets per carton", "ndc": "64380-151-02", "lot_and_expiration": "5501127A and 5501236A (exp. 2025-04); 5501341A (exp. 2025-06); 5501406A (exp. 2025-07); 5501408A (exp. 2025-08); 5501516A (exp. 2025-09); 5501568A (exp. 2025-10); 5501829A (exp. 2026-03); 5502000A (exp. 2026-07); 5502004A and 5502005A (exp. 2026-08); 5502092A (exp. 2026-10); 5502217A (exp. 2026-12); 5502262A (exp. 2027-01)", "reported_quantity": "195,952 cartons (5,878,560 packets calculated)", "reported_quantity_value": 195952, "reported_quantity_unit": "cartons", "calculated_quantity_value": 5878560, "calculated_quantity_unit": "packets", "fda_classification": "Class II", "issue_group": "Benzene", "fda_reason_for_recall": "Presence of foreign substance: Presence of Benzene.", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0293-2025%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" }, { "recall_number": "D-0637-2024", "event_id": "95122", "event_label": "Teva 1.62% gel potency recall", "event_url": "https://api.fda.gov/drug/enforcement.json?search=event_id:95122&limit=100", "recall_initiation_date": "2024-08-08", "recalling_firm": "Teva Pharmaceuticals USA, Inc.", "form": "Gel", "product_summary": "Testosterone gel 1.62%, 1.25 g unit-dose packet, 30 packets per carton", "ndc": "0591-2925-30 (carton); 0591-2925-32 (packet)", "lot_and_expiration": "100042386 (exp. 2025-06)", "reported_quantity": "7,080 unit-dose packets", "reported_quantity_value": 7080, "reported_quantity_unit": "packets", "calculated_quantity_value": null, "calculated_quantity_unit": null, "fda_classification": "Class II", "issue_group": "Superpotent drug", "fda_reason_for_recall": "Superpotent Drug", "fda_record_url": "https://api.fda.gov/drug/enforcement.json?search=recall_number.exact%3A%22D-0637-2024%22&limit=1", "source_export_date": "2026-08-27", "verified_date": "2026-09-03" } ] }