Teva Pharmaceuticals USA recalls Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose
Teva Pharmaceuticals USA recalls Testosterone Gel 1% (2.5g units) due to high drug concentration in stability testing. This may cause unsafe levels of testosterone. Contact for details.
Lower-risk recall
Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
Contact the company & request your remedy
What happened, in plain English
Teva Pharmaceuticals USA is recalling Testosterone Gel 1% products that may have higher-than-stated testosterone levels. This could lead to unsafe hormone exposure if used as directed. Read more at govinfonow.com/recall/36685-teva-testosterone-gel-1-recall-high-drug-concentration-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36685-teva-testosterone-gel-1-recall-high-drug-concentration-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0100-2021
Cite this page
“Teva Testosterone Gel 1% Recall: High Drug Concentration Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36685-teva-testosterone-gel-1-recall-high-drug-concentration-risk. Based on FDA recall #D-0100-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0100-2021%22&limit=1).
Why it’s dangerous
The gel may contain higher-than-stated testosterone levels due to stability testing issues. This could lead to unsafe hormone exposure if used as directed.
Who’s affected
People who have received this testosterone gel for medical treatment. Those with hormone-sensitive conditions may be at higher risk.
How to tell if you have this one
Look for Testosterone Gel 1% products with 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17). These were sold in cartons with NDC 0591-3216-30, manufactured by Actavis Laboratories UT, Inc.
- Brand
Teva Pharmaceuticals USA- Category
Drug
What to do — step by step
Check Product Details
Verify the product label for NDC 0591-3216-17 and 30 Unit-Dose Packets per carton.
Questions people ask
Is this product safe to use?
The recall is due to potential higher-than-stated testosterone levels, but the product is still safe for medical use under supervision.
How do I know if I have the recalled product?
Look for Testosterone Gel 1% with NDC 0591-3216-17 in 2.5 gram Unit-Dose Packets (30 per carton).
What should I do if I have this product?
Check the product details to confirm; if recalled, contact Teva Pharmaceuticals USA for guidance.
Contact Teva Pharmaceuticals USA
We’ve drafted a message you can send Teva Pharmaceuticals USA to request your refund or repair — edit it as you like.
Subject: Recall D-0100-2021 — Teva Pharmaceuticals USA Teva Pharmaceuticals USA Hello, I own a Teva Pharmaceuticals USA that is covered by recall D-0100-2021 from Teva Pharmaceuticals USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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-0100-2021 (November 11, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0100-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.