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

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

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, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-067-11.
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:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.
Product quantity
58,896 bottles- 100's count
Voluntary mandated
Voluntary: Firm initiated
City
Piscataway
State
NJ
Country
United States
Event id
98658
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