Testosterone Recall: FDA Records, Lots and 2026 Data

There is no blanket U.S. testosterone recall in the FDA data we reviewed. In the FDA drug-enforcement export dated August 27, 2026, our written filter found 45 product-level testosterone recall records for recalls started on or after January 1, 2024. Those records map to 11 FDA event IDs, not 45 separate recall actions. One reproduced package calculation yielded 13,210,920 individual gel packets from 440,364 cartons, while the included testosterone records in two pellet events totaled 1,265,965 pellets. We do not combine those unlike units.

The key is the lot. Each FDA record names a certain product, package, National Drug Code (NDC, a three-part code for the labeler, product, and package), lot, or problem. Here, a product record means one FDA recall number, while an event means related product records that share FDA's event_id. The full register below shows which testosterone products were affected and why. An NDC helps identify a listed drug package. It does not, by itself, mean FDA approved the drug.

By TRT Provider Guide

Last verified and updated: September 3, 2026

FDA bulk export used: August 27, 2026

Publisher: TRT Provider Guide

Research section: TRT Provider Guide Research is the research and reference section of TRT Provider Guide

Important: This is a dated research snapshot, not a live recall alert or medical advice. Check the official FDA record and speak with a pharmacist or prescriber before changing prescribed treatment.

Is testosterone recalled in the United States?

Some testosterone products and lots have been recalled, but the FDA data we reviewed does not show one recall covering all testosterone. To know whether a product is affected, match its firm, form, strength, NDC, lot, and expiration date to the official record.

The newest event in this dataset began January 26, 2026. Its 16 included Asteria Health testosterone-containing pellet records report 654,410 pellets and possible metal particulate matter.

A recall number is not a brand-wide warning by itself. One action may cover only one lot, while another may list many strengths as separate product records.

What do the key testosterone recall numbers show?

Our review found 45 product records, 11 FDA event IDs, and 9 distinct recalling firms in the stated date range. Two metal-particle pellet event IDs account for 31 of the 45 included records, which is why the row count looks much larger than the number of separate recall actions.

FDA calls a recall Class II when temporary or medically reversible harm may occur, or when serious harm is unlikely. Class III means harm is not likely. Full context appears below.

Source: TRT Provider Guide analysis of the FDA human-drug enforcement bulk export dated August 27, 2026. The FDA download manifest listed 17,899 total drug-enforcement records in that export.

The 13,210,920-packet figure is a calculation, not a number copied from a headline. FDA reported 440,364 cartons across two Strides gel records, and each product description says there were 30 unit-dose packets per carton. We multiplied 440,364 by 30.

The 1,265,965-pellet figure is also reproducible. It combines 654,410 Asteria testosterone-containing pellets and 611,555 Farmakeio pellets, because both sets of included records use the same unit. We did not add pellets, vials, cartons, and packets into one false grand total.

Data files: CSV register · JSON register · Methodology

What does this testosterone recall data show, and what does it not show?

This dataset shows which recent FDA drug-enforcement records named testosterone as the recalled medicine. It does not measure how often testosterone products fail, how many patients were harmed, or which form is safest.

Source: TRT Provider Guide methodology and calculations based on the FDA drug-enforcement export dated August 27, 2026.

A high row count does not equal a high patient risk. For example, the Asteria event contributed 16 included testosterone rows because different strengths and combinations were listed separately. Those 16 rows still map to one FDA event ID.

The quantity field also needs care. FDA may report one record in pellets, another in cartons, and another in vials. Those units describe different things, so adding them would make a large but meaningless number.

How did we build the testosterone recall dataset?

We downloaded the full FDA human-drug enforcement bulk export, filtered it with a written rule, and cross-checked every included recall number against its official FDA record. We then grouped related rows by FDA event ID and reproduced every published count from the resulting 45-row register.

What was the source?

The source was the FDA's drug-enforcement dataset, which comes from the agency's Recall Enterprise System. FDA says the dataset covers publicly releasable records from 2004 forward, is updated weekly, and includes recalls in the Enforcement Report after classification.

We used the bulk file listed in FDA's download manifest:

• Export date: August 27, 2026
• Total drug-enforcement records in the file: 17,899
• Research verification date: September 3, 2026
• Scope start: January 1, 2024

What did we include?

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.

Combination pellets with testosterone plus anastrozole or triamcinolone were included because testosterone was part of the recalled product named by FDA.

What did we leave out?

We excluded lab tests, medical devices, drug shortages, warning letters without a matching recall record, and class-wide label changes. We also excluded FDA recall D-0511-2024 from the core count because the product was labeled tirzepatide; testosterone cypionate appeared in the reason for the wrong-drug recall, not as the labeled recalled medicine.

How did we count records and events?

A record is one FDA recall number. An event is the group of related product records that share FDA's event_id field.

That difference matters. FDA event 98344 has 25 product records in all. This study includes the 16 rows that name testosterone or a testosterone-containing combination and leaves out 9 estradiol rows under the same event ID. The Farmakeio event ID contributes 15 included testosterone records.

How did we count recalling firms?

We counted the distinct recalling_firm values in the 45 included FDA records. There were 9. We did not merge subsidiaries, parent companies, or other businesses based on a guess.

How did we calculate quantities?

We kept FDA's stated unit for each row. We made a second calculation only when the package description gave a clear multiplier, such as 30 packets per carton.

The formula was:

Calculated packets = reported cartons × packets per carton

We did not estimate missing units. We also did not convert vials, pellets, cartons, or packets into doses, patients, prescriptions, or risk.

What source problem did we preserve?

FDA record D-0129-2026 lists lot 3283 with an incomplete expiration string: /9/2026. We kept that source problem visible and did not guess the missing month or day.

Why do 45 FDA records equal only 11 recall events?

FDA may create a separate recall number for each strength, formula, or package inside one firm action. Grouping by FDA event ID turns the 45 included product rows into 11 distinct event IDs, which is the more honest count of the related recall actions represented here.

Source: TRT Provider Guide grouping of included FDA drug-enforcement records by event_id. Event names are plain-language labels added for this dataset. Dates, firms, classes, quantities, and reasons come from the linked FDA records. The Asteria quantity is the sum of the 16 included testosterone records, not every product in event 98344.

The event table solves a common counting error. Calling this “45 separate testosterone recall events” would make the situation sound much broader than the source data shows.

Which testosterone products, NDCs, and lots were recalled?

The register below contains all 45 product-level FDA records in this study. Match every field you can—especially product, NDC, and lot—because a shared ingredient name alone does not prove that a package is affected.

Source: Each recall number opens its official FDA drug-enforcement record. The register was assembled from the FDA bulk export dated August 27, 2026 and verified September 3, 2026.

For D-0517-2025, FDA says a printing issue caused incorrect lot numbers on the product label. Do not use the printed lot alone to rule that product in or out; confirm it with the pharmacy or recalling firm.

For D-0129-2026, FDA's source text gives an incomplete expiration value for lot 3283. The table preserves that gap instead of filling it with a guess.

Which form appears most often in recent testosterone recall records?

Pellets make up 38 of 45 included records, or 84.4%, but they appear in only 5 of 11 event IDs. That gap is caused by record structure: two pellet actions listed many strengths and combinations as separate rows.

Source: TRT Provider Guide classification of the dosage form named in each FDA product description.

Source: TRT Provider Guide analysis of the FDA human-drug enforcement export dated August 27, 2026. Scope: recalls started on or after January 1, 2024 whose FDA product description named testosterone or a testosterone-containing combination.

These counts are not market share. They do not show how many people use each form, how many units were sold, or which form has a higher failure rate.

Why were the testosterone products recalled?

The most common issue by included product-row count was possible metal particulate matter, with 31 records across two pellet event IDs. The other nine event IDs involved glass particles, sterility concerns, benzene, leakage, labeling, approval status, crystals, or excess strength.

Source: FDA reason_for_recall text, grouped into plain-language issue categories by TRT Provider Guide. The original FDA reason remains in the downloadable register. Percentages are rounded to one decimal and may not sum to 100.0%.

The first two rows explain most of the 45-record count. Two metal-particle event IDs produced 31 included rows, and one glass-particle event ID produced five more. Together, those three event IDs account for 36 of 45 included records, or 80.0%.

The event-ID count tells a different story. Sterility or possible microbial contamination appeared in two separate event IDs. Every other non-metal issue group appeared in one event ID.

What do Class II and Class III mean?

FDA uses recall classes to describe the level of health risk, not the number of products involved. This dataset contains 43 Class II records and 2 Class III records, with no Class I records in the stated date range.

Source: FDA recall definitions and the classification field in each included FDA record.

A Class II recall is not the same as “safe,” and a Class III recall is still a recall. The class also does not tell you whether your package is included; the product and lot fields do that.

How do I check my testosterone lot number?

Start with the package, vial, packet, or pharmacy label and find the product name, NDC, and lot number. A likely match should line up on all key fields, not only the word “testosterone.”

1. Find the recalling firm or manufacturer. The pharmacy name may be different from the firm shown in the FDA record.
2. Match the exact form and strength. A gel recall does not cover an injection simply because both contain testosterone.
3. Find the NDC. The National Drug Code is a package identifier, often shown as three groups of numbers.
4. Find the lot or batch number. It may be labeled “LOT,” “Lot No.,” or “Batch.”
5. Check the expiration date. This helps separate similar lot numbers.
6. Open the FDA record. Use the recall-number source in the register and read the product-specific details.
7. Confirm the match. Ask the dispensing pharmacy, clinic, prescriber, or recalling firm before changing treatment.

FDA tells consumers to compare the lot number on their medicine with the lot in the recall notice. If the package is gone, the pharmacy or clinic may be able to trace the lot from its records.

Implanted pellets can be harder to check because the patient may not have the original package. In that case, ask the clinic that supplied or implanted the pellets for the product, NDC, and lot recorded for the procedure.

What should I do if my lot matches a testosterone recall?

A matching lot should be confirmed through the official recall record, the dispensing pharmacy, the prescriber, or the recalling firm. Do not stop or change prescribed testosterone based only on a broad headline or this research page.

FDA says people can generally keep taking medicine involved in Class II or Class III recalls unless the recalling company or FDA gives other instructions. FDA also warns that stopping a medicine can sometimes be more harmful than continuing it, so follow the product-specific directions and speak with a doctor or pharmacist.

Keep the package, label, and any notice you received. The recall instructions may tell you to return the medicine, replace it, or take another product-specific step.

Are testosterone label changes, shortages, and test recalls the same as a drug recall?

No. A drug recall, a prescribing-label change, a shortage, and a laboratory-device recall are different actions, even though all may appear in a search for “testosterone recall.”

Source: FDA's February 2025 testosterone labeling action, FDA Testosterone Information updated in June 2026, FDA's Access Testosterone device-recall record, FDA Drug Shortages, and FDA drug recall D-0511-2024.

Was the February 2025 testosterone label change a recall?

No. On February 28, 2025, FDA announced class-wide changes to testosterone prescribing information, including changes tied to cardiovascular and blood-pressure evidence. That action changed labels; it did not identify product lots for removal.

Was the June 2026 testosterone label update a recall?

No. FDA's June 2026 update concerned prescribing language, including the age-related-use limitation and prostate safety information. It did not recall named NDCs or lots.

Was a testosterone blood test recalled?

Yes, but it was a separate medical-device recall. FDA recall Z-1901-2025 covered the Beckman Coulter Access Testosterone assay, catalog 33560, lot 538081, with 70 units in commerce.

FDA said cross-contamination could raise a patient result by up to 34% or lower it by up to 23%. That was a lab reagent used to measure testosterone, not testosterone medicine.

Is a testosterone shortage a recall?

No. A shortage means supply is limited or disrupted, while a recall removes or corrects a product because of a problem. A medicine can be in shortage without being recalled, and a recalled medicine may not be in shortage.

Why does this testosterone recall data matter now?

Recent label news and product recalls can look alike in a headline, while FDA's row structure can make one event ID look like many separate recalls. In this dataset, the single Asteria event started in 2026 and contributed 16 of the 45 included product records, or 35.6% of the full row count.

Source: Recall initiation dates in the 45-record dataset, grouped by calendar year.

FDA says not every recall receives a press announcement or news coverage. All recalls monitored by FDA appear in its Enforcement Report after classification, which is why we used the full enforcement export rather than a list of press releases.

The year table also shows why “45 recalls in 2026” would be wrong. Only one event ID represented in this dataset began in 2026; it contributed 16 included product rows. Nine events began in 2025, and one began in 2024.

What are the limits of this testosterone recall data?

This is a dated snapshot of FDA records, not a real-time safety system. FDA can correct or expand recall information after it first appears in an Enforcement Report.

The main limits are:

• The source has a cutoff. We used the FDA export dated August 27, 2026. A later action will not appear until the dataset is refreshed.
• The history starts in 2024. This is not a complete list of every older testosterone recall.
• FDA's drug-recall status field is not a live lifecycle tracker. FDA says openFDA does not update that status after classification.
• Records are not patients. A row does not show how many people used the product or were harmed.
• Quantities are not interchangeable. Pellets, vials, cartons, and packets cannot be added into one honest total.
• Form counts are not failure rates. The dataset has no denominator for how much gel, injectable testosterone, or pellet product was sold or used.
• Classification is not an individual medical decision. A recall class describes FDA's hazard assessment; it does not replace product-specific advice.
• Source fields can be incomplete. FDA record D-0129-2026 has an incomplete expiration entry, which we left incomplete.
• The dataset can change. FDA says it may correct or expand older recall information.

FDA also states that openFDA should not be used by itself to make medical-care decisions or issue public alerts. Use this page to find the relevant official record, then confirm what it means for a specific product with a qualified professional.

What else do people ask about testosterone recalls?

Most questions come down to one check: does the exact product and lot match an FDA record? The answers below summarize the 45-row register without turning a narrow recall into a warning about every testosterone product.

Is all testosterone recalled?

No. We found no single event in this date-scoped FDA dataset that recalled every testosterone product. The 45 records name specific products, firms, strengths, packages, lots, or defects.

Is there a testosterone recall in 2026?

Yes. The event started January 26, 2026. Its 16 included Asteria Health testosterone-containing pellet records report 654,410 pellets. FDA listed possible metal particulate matter as the reason.

Was testosterone gel recalled?

Yes, but only certain products and lots in this review. The records include two Strides Testosterone Gel 1% products recalled for benzene, one Teva 1% gel lot recalled for a leaking packet seal, and one Teva 1.62% gel lot recalled because it was superpotent.

Was testosterone cypionate recalled?

Yes, in specific injection records. These include Eugia lot 1TC24075A, Empower lot 202364, and TESTO-200 lot P-24-1; each had a different reason and none represents a recall of every testosterone cypionate product.

Were testosterone pellets recalled?

Yes. Pellets appear in five event IDs and account for 38 included product records in this dataset. The 31 included testosterone records from the two metal-particle events report 1,265,965 pellets.

How do I find my testosterone lot number?

Look for “LOT,” “Lot No.,” or “Batch” on the vial, packet, carton, or pharmacy label. Match it with the product, strength, NDC, and expiration date, then confirm the result through the FDA record or your pharmacy.

What if my pharmacy label does not show a lot number?

Ask the dispensing pharmacy or clinic to trace the product from its records. This is especially important for implanted pellets, because the patient may never receive the original package.

Does “ongoing” mean the recalled product is still on the market?

Not necessarily in openFDA's drug-enforcement data. FDA says the status field is not updated after a drug recall is classified, so it should not be used as a live measure of whether affected stock remains available.

Should I stop testosterone if my lot is listed?

Do not make that decision from this page alone. FDA says patients can generally continue a Class II or Class III medicine unless other instructions are given, and stopping can sometimes be more harmful; ask a pharmacist or prescriber and follow the official recall directions.

Is an FDA testosterone label change the same as a recall?

No. Label changes update prescribing information. A drug recall names a product, lot, package, or defect that must be removed or corrected.

Was a testosterone lab test recalled?

Yes. The Access Testosterone assay recall involved one lab-reagent lot and 70 units, not testosterone medicine. FDA said the issue could change patient test results by as much as 34% upward or 23% downward.

Related TRT research: FDA-approved testosterone products · TRT side effects statistics · Testosterone levels by age · TRT guidelines compared

How to cite this page

How should this page be cited?

This page and its dataset have separate citation formats. Both include the title, publisher, version date, and stable page address so the exact research snapshot is clear.

Page citation: TRT Provider Guide. “Testosterone Recall: FDA Records, Lots and 2026 Data.” Last verified September 3, 2026. https://trtproviderguide.com/research/testosterone-recall/

Dataset citation: TRT Provider Guide. “U.S. Testosterone Recall Register, 2024–2026.” Version 2026-09-03. https://trtproviderguide.com/research/testosterone-recall/#dataset

Which primary sources support this page?

The core data comes from FDA's full drug-enforcement export and the official record tied to each recall number. Interpretation sections use FDA guidance, FDA definitions, FDA labeling notices, and the official device-recall record.

• FDA drug-enforcement dataset overview
• FDA download manifest
• FDA human-drug enforcement bulk export
• FDA: Understanding Drug Recalls—What to Know and What to Do
• FDA recall background and Class I, II, and III definitions
• FDA Enforcement Reports
• FDA February 2025 class-wide testosterone labeling changes
• FDA Testosterone Information, updated June 2026
• FDA Class 2 Device Recall: Access Testosterone
• FDA Drug Shortages
• FDA National Drug Code Directory

Editorial note: We preserved FDA source wording when it was incomplete, separated drug recalls from related but different actions, and did not turn record counts into patient counts or risk estimates.