Multi-event October 2025 FDA Recall Prazosin Hydrochloride by Teva Pharmaceuticals Usa, Inc
This Multi-event Class II drug recall was voluntarily initiated by Teva Pharmaceuticals Usa, Inc on October 7, 2025 for the product Prazosin Hydrochloride. The FDA reported the reason for recall as 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.. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0105-2026
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.
10-07-2025
11-05-2025
291,512 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10
Batch or Lot Expiration Information
Lot# 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
Recall Number: D-0104-2026
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.
10-07-2025
11-05-2025
181,659 bottles
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# 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
Recall Number: D-0106-2026
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.
10-07-2025
11-05-2025
107,673
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Teva Pharmaceuticals USA, Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# 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
