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

Appco Pharma LLC: Prazosin Hydrochloride Capsules, USP, 1mg, 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, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.
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:2404160C, Exp.:2026/MAR; 2406253C, Exp.:2026/MAY; 2407311C, Exp.: 2026/JUL; 2407312C, Exp.:2026/JUL; 2408350C, Exp.:2026/JUL; 2505172C, Exp.:2027/MAY; 2506191C, Exp.: 2027/JUN.
Product quantity
88,008 bottles- 100's count
Voluntary mandated
Voluntary: Firm initiated
City
Piscataway
State
NJ
Country
United States
Event id
98658
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