FDA Drugs recall ·

Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons… recall

Recall number
D-0102-2026
Date
(initiated October 16, 2025)
Company / brand
Amerisource Health Services LLC
2550 John Glenn Ave Ste A, Columbus, OH, United States
Category
Drugs › Class II
Classification
Class II
Status
Ongoing
Units affected
1,818 cartons
Hazard tags
Potency
Initiated by
Voluntary: Firm initiated

Read the official FDA notice ↗

Product

Prazosin Hydrochloride, Capsules, USP, 2 mg, 100 capsules (10x10) cartons, Rx only, Distributed by American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-997-01, Individual unit dose: NDC 68084-997-11

Why was it recalled?

Failed Impurities/Degradation Specification: presence of N-nitroso Prazosin impurity C above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit

What should you do?

FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.

Product codes & lot numbers

Lot #: 1020109, Exp. Date 02/28/2026; 1024343, 1025355, Exp. Date 09/30/2026.

Distribution

Nationwide within the United States

What does Class II mean?

Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.

Source: FDA (drugs), recall D-0102-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.