Prazosin Hydrochloride Capsules Recalled Nationwide for Excessive Carcinogenic Impurity Levels
Amerisource Health Services recalls Prazosin Hydrochloride 5 mg capsules due to excess carcinogenic impurity. The affected lots distributed nationwide contain N-nitroso Prazosin impurity above safe limits.
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 involving a prescription drug with a known carcinogenic impurity above acceptable regulatory limits. No illnesses or injuries have been reported, so per the rubric the score does not exceed 3 (High), which applies to risk-of-harm products where injury has not yet been reported.
Plain-English summary
Amerisource Health Services LLC is recalling Prazosin Hydrochloride capsules, 5 mg strength, distributed nationwide. The recall affects 3,410 cartons. Prazosin Hydrochloride is a prescription medication.
The recall was initiated because certain lots contain N-nitroso Prazosin impurity C at levels that exceed the FDA's Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit. N-nitroso compounds are known carcinogens, and the presence of this impurity above safe levels raises health concerns.
Patients currently taking affected lots of Prazosin Hydrochloride should contact their healthcare provider or pharmacist to verify whether their medication is part of this recall. Do not stop taking the medication without medical guidance. The affected lot numbers are 1016996, 1018336, 1021220 (expiring 11/30/2025) and 1022421, 1025017 (expiring 08/31/2026).
The recalled product
- Product
- PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
- Brand
- PRAZOSIN HYDROCHLORIDE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Hazard
- carcinogenic-impurity
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 (7)
- Lot #: 1016996
- 1018336
- 1021220
- Exp. Date 11/30/2025
- 1022421
- 1025017
- Exp. Date 08/31/2026.
Distribution
Distributed nationwide across the United States.
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