Class II · ModerateActive recall
Prazosin Hydrochloride
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numbera) NDC [redacted-phone]: Lot # 3010544A and 3010545A, Exp Date: 10/2025; Lot # 3010567A, Exp Date: 12/2025; Lot # 3010590A, Exp Date: 02/2026; Lot # 3010601A, 3010602A, 3010603A, Exp Date: 03/2026; Lot # 3010652A, 3010670A, 3010671A, Exp Date: 07/2026; Lot # 3010678A, 3010700A, 3010701A, Exp Date: 08/2026 b) NDC [redacted-phone]: Lot # 3010440A, Exp Date: 12/2025; Lot # 3010672A, Exp Date: 07/2026
Where it was soldU.S. Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
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.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byTeva Pharmaceuticals USA, Inc.
| Brand name | PRAZOSIN HYDROCHLORIDE |
| Generic name | PRAZOSIN HYDROCHLORIDE |
| Active ingredient(s) | PRAZOSIN HYDROCHLORIDE |
| Distributed by / for | TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules |
| NDC | 0093-4067-01 |
Show the full FDA record
| Full product label | Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4067-01, b) 1000 Capsules, NDC 0093-4067-10 |
| Recalling firm | Teva Pharmaceuticals USA, Inc |
| Distribution | U.S. Nationwide |
| Quantity | 181,659 bottles |
| Recall initiated | 2025-10-07 |
| Report date | 2025-11-05 |
| Recall completed | — |
| Recall number | D-0104-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Parsippany NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.