⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

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

DrugsSource: FDA (drug) · Date: 2026-04-08

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Appco Pharma LLC
Product
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 70377-068-11.
Reason / hazard
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S.A. Nationwide
Recall initiated
2026-03-27
Code info
Lot:2406255UC, Exp.: 2026/MAY; 2406256UC, Exp.: 2026/JUL; 2407313UC Exp.: 2026/JUL; 2408351UC, Exp.: 2026/JUL; 2408352UC , Exp.: 2026/JUL; 2509311UC, Exp.: 2027/SEP. .
Product quantity
28,157 bottles- 100's count
Voluntary mandated
Voluntary: Firm initiated
City
Piscataway
State
NJ
Country
United States
Event id
98658
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