Teva Recalls Prazosin Hydrochloride Capsules for Carcinogenic Impurity
Teva Pharmaceuticals recalls Prazosin Hydrochloride 1 mg capsules nationwide due to N-nitroso impurity levels exceeding FDA acceptable limits. Patients should consult their healthcare provider.
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: FDA Class II recall involving a carcinogenic N-nitroso impurity measured above acceptable limits. No illnesses or injuries reported, but the presence of a known carcinogen in a prescription medication represents a significant health risk warranting High severity.
Plain-English summary
Teva Pharmaceuticals USA, Inc. is recalling Prazosin Hydrochloride 1 mg capsules distributed nationwide. The recall affects multiple lot numbers with expiration dates ranging from October 2025 through August 2026.
The recall is due to test results showing N-nitroso Prazosin impurity C above the FDA's Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit. This represents a Current Good Manufacturing Practice (CGMP) deviation. N-nitroso compounds are known carcinogens.
Patients who have been prescribed this medication should consult their pharmacist or healthcare provider to determine if they have received affected lots. Do not stop taking your medication without medical guidance.
Questions should be directed to Teva Pharmaceuticals USA, Inc. or the FDA.
The recalled product
- Product
- PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
- Brand
- PRAZOSIN HYDROCHLORIDE
- Manufacturer
- Teva Pharmaceuticals USA, Inc
- Category
- Drug — Prescription Drug
- Hazard
- carcinogen
- contamination
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.
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