Testosterone Gel 1% — Class II drug recall D-1289-2022
Terminated recall by Teva Pharmaceuticals USA Inc, reported 2022-08-03, distributed nationwide. Superpotent Drug: Out of specification assay result was obtained during stability testing.
| Recall number | D-1289-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA Inc, Parsippany, NJ, United States |
| Recall initiated | 2022-06-29 |
| Classified | 2022-07-25 |
| Reported by FDA | 2022-08-03 |
| Terminated | 2024-03-15 |
| Distributed | Nationwide (US) |
| Quantity | 12,354 cartons |
| Reason classes | potency, specification failure |
| NDC | 00591-2921, 00591-2921-02, 00591-2921-18, 00591-3216, 00591-3216-17, 00591-3216-30, 00591-3217, 00591-3217-26, 00591-3217-30 |
| Lot numbers | 1403180 |
| Expiration dates | 2022-10 |
Product
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box. Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, US 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA, Sachet NDC 0591-3216-17, Carton NDC 0591-3216-30
Reason for recall
Superpotent Drug: Out of specification assay result was obtained during stability testing.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1289-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.