Teva Prazosin Hydrochloride Capsules Recalled for Carcinogenic Impurity Levels
Teva Pharmaceuticals recalls Prazosin Hydrochloride 2 mg capsules containing N-nitroso Prazosin impurity above FDA's acceptable intake limit. Affected lots were distributed nationwide.
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: This is an FDA Class II recall for N-nitroso Prazosin impurity exceeding the carcinogenic potency acceptable intake limit. No illnesses or injuries have been reported, classifying this as a risk-of-harm product where injury has not yet occurred, consistent with High severity.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling Prazosin Hydrochloride 2 mg capsules distributed nationwide. The recall affects 291,512 bottles across multiple lot numbers.
The recall is due to a Current Good Manufacturing Practice (CGMP) deviation. Testing revealed that N-nitroso Prazosin impurity C exceeds the FDA's Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit in the affected lots.
The affected product is distributed in 100-capsule and 1,000-capsule bottles with various lot numbers and expiration dates ranging from October 2025 through February 2027. Specific NDC codes affected are 0093-4068-01 and 0093-4068-10.
Consumers taking this medication should contact their healthcare provider or pharmacist. Patients should verify whether their medication lot is affected using the lot number on their bottle and consult their pharmacy for guidance on obtaining a replacement or alternative.
The recalled product
- Product
- PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
- Brand
- PRAZOSIN HYDROCHLORIDE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug
- Hazard
- carcinogenic-impurity
- nitrosamine
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.
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