Prazosin Hydrochloride Recall: Teva 5 mg
Announced 2026-05-13 · FDA
FDA is recalling Teva Prazosin Hydrochloride capsules due to CGMP deviations and test results showing N-nitroso Prazosin impurity above CPCA acceptable intake limit. The affected lots span NDC 0093-4069-01, 0093-4069-52, and 0093-4069-05 with multiple lot numbers and expiration dates through 02/2027. About 107,673 units were distributed nationwide in the U.S.
| Brand | Teva Pharmaceuticals USA, Inc |
|---|---|
| Product | Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4069-01, b) 250 Capsules, NDC 0093-4069-52, c) 500 Capsules, NDC 0093-4069-05 |
| Reason | CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots. |
| Severity | moderate |
| Units affected | 2200 |
| Distribution | U.S. Nationwide |
| Agency | FDA |
| Recall / campaign no. | a) NDC 0093-4069-01: Lot # 3010403A, 3010385A, 3010404A, Exp Date: 02/2026; Lot # 3010405A, 3010510A, 3010528A, 3010354A, Exp Date: 03/2026; Lot # 3010592A, 3010605A, 3010611A, 3010612A, Exp Date: 08/2026; Lot # 3010655A, 3010703A, Exp Date: 02/2027 b) NDC 0093-4069-52: Lot # 3010430A, Exp Date: 11/2025, Lot # 3010613A, Exp Date: 08/2026 c) NDC 0093-4069-05: Lot # 3010406A, Exp Date: 02/2026 |
WHAT YOU SHOULD DO
- Do not use the recalled products.
- Check your NDC and lot numbers against the affected listings and set aside any affected packaging.
- Contact your pharmacist or Teva for instructions on returning or disposing of the product and for possible replacement.
- If you have questions or have experienced any health issues, consult your healthcare provider.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.