FDA Drug recall D-1289-2022
Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box
- FDA Drug
- Class II
- terminated
- Published 2022-08-03
On 2022-08-03 the FDA classified a Class II recall of Testosterone Gel 1% (25mg testosterone/2.5g of gel) 2.5 g per unit dose, Rx Only, 30 unit-dose packets per box by Teva Pharmaceuticals Usa, citing superpotent Drug: Out of specification assay result was obtained during stability testing.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1289-2022 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2022-06-29 |
| Published | 2022-08-03 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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
Superpotent Drug: Out of specification assay result was obtained during stability testing.
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: 1403180, EXP. 10/2022 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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All Teva Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1289-2022%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.