Class II
Drug Recall: Prazosin Hydrochloride, Capsules, USP, 2 mg, Rx only, Distributed by TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, a) 100 Capsules, NDC 0093-4068-01, b) 1000 Capsules, NDC 0093-4068-10
Teva Pharmaceuticals USA, Inc · October 7, 2025
Reason for Recall
CGMP Deviations-Test results for N-nitroso Prazosin impurity C that are above the Carcinogenic Potency Categorization Approach (CPCA) acceptable intake limit for the above specified lots.
Distribution
U.S. Nationwide
States Affected
NATIONWIDE
Quantity Affected
291,512 bottles
Source: FDA (openFDA Drug Enforcement)
Recall number: D-0105-2026
Status: ongoing
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