--- title: "Testosterone Recall Register Methodology" description: "Inclusion rules, counting rules, calculations, normalization and limits for the U.S. Testosterone Recall Register, version 2026-09-03." datePublished: "2026-09-03" dateModified: "2026-09-03" lastVerified: "2026-09-03" publisher: "TRT Provider Guide" --- # Testosterone Recall Register Methodology **Dataset:** U.S. Testosterone Recall Register, 2024–2026 **Version:** 2026-09-03 **Verified:** September 3, 2026 **Source export date:** August 27, 2026 **Page:** https://trtproviderguide.com/research/testosterone-recall/ ## Source The source is FDA's human-drug enforcement dataset from the Recall Enterprise System. - Dataset overview: https://open.fda.gov/apis/drug/enforcement/ - Download manifest: https://api.fda.gov/download.json - Bulk export: https://download.open.fda.gov/drug/enforcement/drug-enforcement-0001-of-0001.json.zip - Records listed in that export: 17,899 - Export date: August 27, 2026 ## Inclusion rule A row was included only when all four rules were met: 1. It appeared in the FDA human-drug enforcement dataset. 2. Its `recall_initiation_date` was January 1, 2024 or later. 3. Its FDA product description named testosterone or a testosterone-containing combination as the recalled medicine. 4. It had a unique FDA recall number. The text check was applied to the product description, not to the recall reason. That keeps a wrong-drug event from entering the dataset only because the reason mentions testosterone. Combination pellets were included when testosterone was part of the recalled medicine named by FDA. ## Exclusions The register leaves out laboratory tests, medical devices, drug shortages, warning letters without a matching drug-recall record, and class-wide label changes. FDA recall D-0511-2024 was excluded. The labeled product was tirzepatide. Testosterone cypionate appeared in the reason because FDA said some vials contained the wrong drug. Testosterone was not the labeled recalled medicine. ## Record, event and firm counts - **Record:** one unique FDA `recall_number`. - **Event ID:** the FDA `event_id` shared by related product records. - **Firm:** one distinct `recalling_firm` value in the included records. The 45 included records map to 11 FDA event IDs and 9 distinct recalling-firm values. FDA event 98344 returns 25 product records in all. The register includes the 16 rows that name testosterone or a testosterone-containing combination and excludes 9 estradiol rows under that same event ID. The event-level Asteria quantity on the page is therefore the sum of the 16 included testosterone rows, not every product in event 98344. No subsidiaries, parent companies or related businesses were merged based on an editorial guess. ## Editorial fields The downloadable files keep source and editorial fields separate. **Source-based fields** - FDA recall number - FDA event ID - recall initiation date - recalling firm - NDC - lot and expiration text - reported quantity - FDA classification - FDA `reason_for_recall` - official FDA record URL **Editorial fields** - event label - dosage-form group - product summary - issue group Event labels are short plain-language names. The form groups are Pellet, Gel and Injection. Issue groups combine source wording only when the underlying problem is the same. The exact FDA reason remains in `fda_reason_for_recall`. ## Quantity rules FDA reports different units across records. The register keeps each source unit. - Pellets stay pellets. - Vials stay vials. - Cartons stay cartons. - Packets stay packets. Unlike units are never added into one total. A calculated packet count was added only when the product description gave an explicit package multiplier: **Calculated packets = reported cartons × packets per carton** Reproduced calculations: - Strides: 440,364 cartons × 30 packets = 13,210,920 packets. - Teva 1% gel: 15,944 cartons × 30 packets = 478,320 packets. - Asteria included testosterone rows: 654,410 pellets. - Farmakeio included rows: 611,555 pellets. - Same-unit pellet sum: 654,410 + 611,555 = 1,265,965 pellets. The 7,080 packets in FDA record D-0637-2024 are FDA's reported quantity. They are not an added package calculation. No quantity was converted into doses, prescriptions, patients or risk. ## Source defects FDA record D-0129-2026 lists lot 3283 with the incomplete expiration string `/9/2026`. The register preserves that string and does not guess the missing month or day. FDA record D-0517-2025 concerns incorrect lot numbers printed on labels. The register keeps FDA's listed lot information and tells readers to confirm the affected product with the pharmacy or recalling firm. ## Quality checks Before publication, the register was checked for: - 45 rows and 45 unique recall numbers - 11 unique FDA event IDs - 9 distinct recalling-firm values - 38 pellet, 4 gel and 3 injection records - 43 Class II and 2 Class III records - 1 record started in 2024, 28 in 2025 and 16 in 2026 - event-level sums and package multipliers - one official FDA record link for every included recall number - visible preservation of the incomplete D-0129-2026 expiration string - exclusion of D-0511-2024 from the core count ## Limits This is a dated snapshot, not a live alert. The source cutoff is August 27, 2026. The history begins January 1, 2024. FDA can correct or expand older information. The openFDA status field is not updated after a drug recall is classified. Record counts are not patient counts, market share, failure rates or proof of harm. openFDA should not be used by itself to make medical-care decisions or issue public alerts. A reader should use the register to reach the official FDA record, then confirm a product match with the dispensing pharmacy, prescriber or recalling firm. ## Suggested dataset citation TRT Provider Guide. “U.S. Testosterone Recall Register, 2024–2026.” Version 2026-09-03. https://trtproviderguide.com/research/testosterone-recall/#dataset