Prazosin 5 mg capsules recalled over nitrosamine impurity above intake limit
Teva Pharmaceuticals USA is recalling 107,673 units of Prazosin Hydrochloride Capsules 5 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, 5 mg, distributed by Teva Pharmaceuticals USA of North Wales, Pennsylvania, are being recalled for CGMP deviations. The 100-capsule (NDC 0093-4069-01), 250-capsule (NDC 0093-4069-52) and 500-capsule (NDC 0093-4069-05) presentations 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 107,673 units, including lots 3010403A, 3010385A and 3010404A expiring February 2026, 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 (20)
- 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
UPCs (3)
- 0300934068016
- 0300934069013
- 0300934067019
Distribution
Distributed nationwide across the United States.
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