Prazosin 1 mg capsules recalled over nitrosamine impurity above intake limit
Teva Pharmaceuticals USA is recalling 181,659 bottles of Prazosin Hydrochloride Capsules 1 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Scored 3 under the risk-of-harm criterion: a named nitrosamine impurity above its acceptable intake limit is a defined safety threshold breach, with no injuries reported.
Plain-English summary
Prazosin Hydrochloride Capsules, USP, 1 mg, distributed by Teva Pharmaceuticals USA of North Wales, Pennsylvania, are being recalled for CGMP deviations. Both the 100-capsule bottle (NDC 0093-4067-01) and the 1,000-capsule bottle (NDC 0093-4067-10) are affected.
Test results for the N-nitroso Prazosin impurity C were above the acceptable intake limit set by the Carcinogenic Potency Categorization Approach for the specified lots.
The recall covers 181,659 bottles, including lots 3010544A and 3010545A (which expired October 2025) and lot 3010567A (which expired December 2025), and was distributed nationwide in the United States. The FDA has classified the recall as Class II.
Prazosin is a prescription medicine, so patients should check their bottle's lot number against the firm's list and contact their pharmacy or prescriber about a replacement rather than stopping treatment on their own.
The recalled product
- Product
- PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
- Brand
- PRAZOSIN HYDROCHLORIDE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Antihypertensive
- Hazard
- nitrosamine
- impurity
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (19)
- 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
- Lot # 3010672A
UPCs (3)
- 0300934068016
- 0300934069013
- 0300934067019
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · PRAZOSIN HYDROCHLORIDE
- HighPrazosin hydrochloride tablets recalled over nitrosamine impurity above limits
FDA (Drugs) · 2026-04-08
- HighPrazosin hydrochloride further lots recalled over nitrosamine impurity levels
FDA (Drugs) · 2026-04-08
- HighPrazosin hydrochloride 100-count bottles recalled over nitrosamine impurity
FDA (Drugs) · 2026-04-08
- HighPrazosin 5 mg capsules recalled over nitrosamine impurity above intake limit
FDA (Drugs) · 2025-11-05
- HighPrazosin capsules recalled over nitrosamine impurity above the acceptable intake limit
FDA (Drugs) · 2025-11-05
Same category
- SevereCleviprex Injectable Emulsion Recall Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-07-22
- ModerateQuality Choice Earwax Removal Kit Carbamide Peroxide Subpotent Drug Recall
FDA (Drugs) · 2026-07-22
- ModerateFamily Wellness Carbamide Peroxide Earwax Removal Kit Subpotent Drug
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22