HIGH

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.

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

Quick Facts at a Glance

Recall Date
March 27, 2026
Hazard Level
HIGH
Brands
PRAZOSIN HYDROCHLORIDE, Biocon Pharma Inc.
Geographic Scope
1 states

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Appco Pharma LLC or your healthcare provider for guidance. Notification method: E-Mail

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Full Description

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.. Generic: PRAZOSIN HYDROCHLORIDE; Brand: PRAZOSIN HYDROCHLORIDE. Reason: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.. Classification: Class II. Quantity: 88,008 bottles- 100's count. Distribution: U.S.A. Nationwide

View Original Recall on FDA - Drug Safety

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Product Classification

Product Details

Model Numbers
Lot:2404160C
Exp.:2026/MAR
2406253C
Exp.:2026/MAY
2407311C
+9 more
UPC Codes
70377-066
70377-067
70377-068
+3 more
Affected States
ALL
Report Date
April 8, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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