Unit dose prazosin 2 mg cartons recalled over nitrosamine impurity
Amerisource Health Services is recalling 1,818 unit dose cartons of Prazosin Hydrochloride Capsules 2 mg over N-nitroso Prazosin impurity C above 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, 2 mg, in 100-capsule (10x10) unit dose cartons distributed by American Health Packaging of Columbus, Ohio, are being recalled for failed impurities and degradation specifications.
The recall follows the presence of N-nitroso Prazosin impurity C above the acceptable intake limit set by the Carcinogenic Potency Categorization Approach.
The recall covers 1,818 cartons from lot 1020109 (expiring 28 February 2026) and lots 1024343 and 1025355 (expiring 30 September 2026), carrying carton NDC 68084-997-01 and unit dose NDC 68084-997-11. The product was distributed nationwide in the United States. The FDA has classified the recall as Class II.
This is a unit dose presentation used in institutional settings. Facilities and pharmacies holding an affected lot should quarantine it and follow the firm's instructions; patients should speak to their pharmacy or prescriber rather than stopping treatment on their own.
The recalled product
- Product
- PRAZOSIN HYDROCHLORIDE (PRAZOSIN HYDROCHLORIDE)
- Brand
- PRAZOSIN HYDROCHLORIDE
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug — Antihypertensive
- Hazard
- nitrosamine
- impurity
- unit-dose
- out-of-specification
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 (5)
- Lot #: 1020109
- Exp. Date 02/28/2026
- 1024343
- 1025355
- Exp. Date 09/30/2026.
Distribution
Distributed nationwide across the United States.
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