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Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 7037…

cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.

Class II Medicine & devices FDA April 8, 2026 Reached Texas
Read the official FDA notice →

What to do

Stop using the product and check it against the description above. Follow the remedy on the official notice; most recalls are refunded or replaced without a receipt. If you or a family member has already been affected, keep the packaging and the lot code — they're what a claim rests on later.

Details

Recalling company
Appco Pharma LLC — Piscataway, NJ
Severity
Class II — moderate
Reported
April 8, 2026
Quantity
28,157 bottles- 100's count
Recall number
D-0421-2026
Status
Ongoing
Source
FDA

Where it went

U.S.A. Nationwide

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