Teva Recalls Testosterone Gel 1% Due to Assay Issues
Teva Pharmaceuticals recalls specific lots of Testosterone Gel 1% due to out-of-specification assay results. Check your lot number and expiration date.
Use caution until it’s fixed
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Contact the company
What happened, in plain English
Teva Pharmaceuticals USA Inc is recalling Testosterone Gel 1% because stability testing revealed an out-of-specification assay result. This means the drug may not contain the correct amount of active ingredient. The recall affects 12,354 cartons distributed nationwide in the USA. Read more at govinfonow.com/recall/34481-teva-recalls-testosterone-gel-1-due-to-assay-issues.
Source Summary by GovInfoNow · govinfonow.com/recall/34481-teva-recalls-testosterone-gel-1-due-to-assay-issues · Updated October 10, 2026 · FDA enforcement record: FDA #D-1289-2022
Cite this page
“Teva Recalls Testosterone Gel 1% Due to Assay Issues.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/34481-teva-recalls-testosterone-gel-1-due-to-assay-issues. Based on FDA recall #D-1289-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1289-2022%22&limit=1).
Why it’s dangerous
The hazard is that the gel's assay result was out of specification during stability testing. This indicates the testosterone content may be higher or lower than labeled, potentially affecting treatment efficacy or safety.
Who’s affected
Patients prescribed Testosterone Gel 1% who purchased the specific recalled lots are affected. Individuals using this medication for hormone replacement therapy are most at risk of receiving a product with incorrect potency.
How to tell if you have this one
Check your box for Sachet NDC 0591-3216-17 and Carton NDC 0591-3216-30. Look for Lot number 1403180 with an expiration date of 10/2022. The product is distributed by Actavis Pharma, Inc.
- Brand
Teva Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Product Details
Verify if your Testosterone Gel matches the recalled NDCs and Lot number 1403180 expiring in 10/2022.
Contact Your Healthcare Provider
Speak with your doctor or pharmacist about discontinuing use or obtaining a replacement if you have the recalled product.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 21 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Similar recalls
Other Teva Pharmaceuticals recalls
Latest drug recalls
Keep exploring
Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-1289-2022 (June 29, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1289-2022 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.