Prazosin capsules recalled over nitrosamine impurity above the acceptable intake limit
Teva Pharmaceuticals USA is recalling 291,512 bottles of Prazosin Hydrochloride Capsules 2 mg because test results for N-nitroso Prazosin impurity C exceeded the acceptable intake limit.
The agency’s classification
FDA (Drugs): Class II
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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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, 2 mg, distributed by Teva Pharmaceuticals USA of North Wales, Pennsylvania, are being recalled for CGMP deviations. Both the 100-capsule bottle (NDC 0093-4068-01) and the 1,000-capsule bottle (NDC 0093-4068-10) 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 291,512 bottles 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
- Affected units
- 291,512
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 0093-4068-01: 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
UPCs (3)
- 0300934068016
- 0300934069013
- 0300934067019
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Teva Pharmaceuticals USA, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
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