Drug & Device Safety Atlas

FDA drug recalls · openFDA

Is PRAZOSIN HYDROCHLORIDE recalled?

The FDA has recorded 9 recalls of PRAZOSIN HYDROCHLORIDE (2025–2026) , recalled under brand like PRAZOSIN HYDROCHLORIDE. 9 still ongoing.

0
Class I (most serious)
9
Class II
0
Class III
9
ongoing

A recall doesn't mean your pills are affected

Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of PRAZOSIN HYDROCHLORIDE ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.

Why it was recalled

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above ac 3
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Ap 3
Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Ca 3

The recalls

Class I and ongoing recalls first. Tap a recall for its full record and lot detail.

Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Class II ongoing
Appco Pharma LLC 2026-03-27 lots: Lot:2404160C, Exp.:2026/MAR; 2406253C, Exp.:2026/MAY; 2407311C, Exp.: 2026/JUL; 2407312C, Exp.:2026/JUL; 2408350C, Exp.:2026/JUL; 2505172C, Exp.:2027/MAY; 2506191C, Exp.: 2027/JUN.
Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Class II ongoing
Appco Pharma LLC 2026-03-27 lots: Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Class II ongoing
Appco Pharma LLC 2026-03-27 lots: Lot:2406255UC, Exp.: 2026/MAY; 2406256UC, Exp.: 2026/JUL; 2407313UC Exp.: 2026/JUL; 2408351UC, Exp.: 2026/JUL; 2408352UC , Exp.: 2026/JUL; 2509311UC, Exp.: 2027/SEP. .
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194 Class II ongoing
Teva Pharmaceuticals USA, Inc 2025-10-07 lots: a) NDC 0093-4068-01: Lot # 3010398A, 3010399A, 3010400A, 3010401A, 3010353A, Exp Date: 12/2025; Lot # 3010439A, 3010388A, Exp Date: 01/2026; Lot # 3010526A, 3010527A, Exp Date: 03/2026; Lot # 3010591A, 07/2026; Lot # 3010343A, Exp Date: 10/2025; Lot # 3010352A, Exp Date: 11/2025; Lot # 3010468A, 3010469A, 3010461A, Exp Date: 02/2026; Lot # 3010629A, Exp Date: 09/2026; Lot # 3010653A, Exp Date: 01/2027; Lot # 3010654A, 3010679A, 3010702A, Exp Date: 02/2027; Lot # 3010547A, Exp Date: 04/2026 b) NDC 0093-4068-10: Lot # 3010402A Exp Date: 02/2028; Lot # 3010593A, Exp Date: 07/2026, Lot # 3010610A, Exp Date: 09/2026
Prazosin Hydrochloride, Capsules, USP, 1 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194 Class II ongoing
Teva Pharmaceuticals USA, Inc 2025-10-07 lots: a) NDC 0093-4067-01: 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 0093-4067-10: Lot # 3010440A, Exp Date: 12/2025; Lot # 3010672A, Exp Date: 07/2026
Prazosin Hydrochloride, Capsules, USP, 5 mg, 20 capsules (5x4) cartons, Rx only, Distributed by American Health Packagin Class II ongoing
Amerisource Health Services LLC 2025-10-16 lots: Lot #: 1016996, 1018336, 1021220, Exp. Date 11/30/2025; 1022421, 1025017, Exp. Date 08/31/2026.
Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packa Class II ongoing
Amerisource Health Services LLC 2025-10-16 lots: Lot #: 1020109, Exp. Date 02/28/2026; 1024343, 1025355, Exp. Date 09/30/2026.
Prazosin Hydrochloride, Capsules, USP, 1 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packa Class II ongoing
Amerisource Health Services LLC 2025-10-16 lots: Lot #: 1023526, 1023555, Expiry: 07/31/2026
Prazosin Hydrochloride, Capsules, USP, 5 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 194 Class II ongoing
Teva Pharmaceuticals USA, Inc 2025-10-07 lots: 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

RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.

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