Teva Pharmaceuticals recalls Testosterone Gel 1% (25mg testosterone/2.5g) due to out of specification assay results from stability testing. Affected units have specific NDC and lot numbers.
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Teva Pharmaceuticals is recalling Testosterone Gel 1% products that failed stability testing, meaning the drug concentration might be incorrect. This could lead to improper dosing if used without medical supervision.
The gel failed stability testing, indicating the drug concentration might not match the label. This could cause incorrect dosing if used without medical supervision, but the risk is low since it's a prescription product.
Prescription users of Testosterone Gel 1% who received this specific product. Patients with medical conditions requiring precise hormone levels are at higher risk.
Check for the NDC 0591-321:17 on the sachet and NDC 0591-3216-30 on the carton. Products with lot number 1403180 and expiration date 10/2022 are affected.
Verify the NDC codes and lot number on the product packaging to confirm if it's affected.
The recall is due to potential assay issues, but the product is safe for use if it's not affected. Consult your doctor if you have concerns.
Check the NDC codes and lot number to confirm if it's affected. If it is, contact your healthcare provider for guidance.
The recall record does not specify a replacement process; contact your healthcare provider for assistance.
We’ve drafted a message you can send Teva Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-1289-2022 — Teva Pharmaceuticals Teva Pharmaceuticals Hello, I own a Teva Pharmaceuticals that is covered by recall D-1289-2022 from Teva Pharmaceuticals. 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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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.
