FDA Recall D-0420-2026

Appco Pharma LLC · Piscataway, NJ

Class II Ongoing 48 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.

Lot / code: Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.

Quantity: 58,896 bottles- 100's count

Reason for recall

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

Recall record

Recall number: D-0420-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: E-Mail
Distribution: U.S.A. Nationwide
Recall initiated: 2026-03-27
Classified by FDA Center: 2026-03-31
FDA published: 2026-04-08
Recalling firm: Appco Pharma LLC
Firm location: Piscataway, NJ

Drug identification

Brand name(s): PRAZOSIN HYDROCHLORIDE
Generic name(s): PRAZOSIN HYDROCHLORIDE
Manufacturer(s): Biocon Pharma Inc.
NDC(s): 70377-066, 70377-067, 70377-068
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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