Carton label: Testosterone Gel 1% — Class III drug recall D-0198-2026
Ongoing recall by Teva Pharmaceuticals USA, Inc, reported 2025-12-10, distributed nationwide. Defective Container - A defect in the side-seal which allows leakage of product.
| Recall number | D-0198-2026 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, Inc, Parsippany, NJ, United States |
| Recall initiated | 2025-11-07 |
| Classified | 2025-12-01 |
| Reported by FDA | 2025-12-10 |
| Distributed | Nationwide (US) |
| Quantity | 15,944 cartons |
| Reason classes | packaging |
| 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 | 100068692 |
| Expiration dates | 2027-04-30 |
Product
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc, Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 0591-3216-30. Packet label: Testosterone Gel 1%, contains 2.5 grams, For topical use only, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054,NDC: 0591-3216-17.
Reason for recall
Defective Container - A defect in the side-seal which allows leakage of product.
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-0198-2026. 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.