Testosterone Gel 1% — Class III drug recall D-0100-2021
Terminated recall by Teva Pharmaceuticals USA, reported 2020-11-25, distributed nationwide. Superpotent Drug: High out-of-specification assay results were obtained during stability testing.
| Recall number | D-0100-2021 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Parsippany, NJ, United States |
| Recall initiated | 2020-11-11 |
| Classified | 2020-11-20 |
| Reported by FDA | 2020-11-25 |
| Terminated | 2021-06-24 |
| Distributed | Nationwide (US) |
| Quantity | 12,088 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 | 1351104 |
| Expiration dates | 2021-08 |
Product
Testosterone Gel 1%, 2.5 grams per unit dose, packaged in 2.5 gram Unit-Dose Packets (NDC 0591-3216-17); 30 Unit-Dose Packets per carton (NDC 0591-3216-30), Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108; Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054.
Reason for recall
Superpotent Drug: High out-of-specification assay results were 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-0100-2021. 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.