FDA Drug recall D-0198-2026
Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc…
- FDA Drug
- Class III
- ongoing
- Published 2025-12-10
On 2025-12-10 the FDA classified a Class III recall of Carton label: Testosterone Gel 1%, 2.5 grams per unit dose, CIII, 30 unit-dose packets, Rx only, Manufactured by: Actavis Laboratories, Inc… by Teva Pharmaceuticals Usa, citing defective Container - A defect in the side-seal which allows leakage of product.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0198-2026 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2025-11-07 |
| Published | 2025-12-10 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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
Defective Container - A defect in the side-seal which allows leakage of product.
Identifiers
| ndc | 0591-2921-18 |
|---|---|
| ndc | 0591-2921-02 |
| ndc | 0591-3216-17 |
| ndc | 0591-3216-30 |
| ndc | 0591-3217-26 |
| ndc | 0591-3217-30 |
| code_info | Lot #100068692, Exp.: 04/30/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
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All Teva Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0198-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.