Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,
Summary
The FDA issued a Class II for Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactu by Appco Pharma LLC. Reason: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits..
Details
Source
Drug Recall
External ID
D-0420-2026
Action Date
2026-04-08
Status
Ongoing
Category
drug
Product Description
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 Info: Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.
Quantity Affected: 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.
Distribution
U.S.A. Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-03-27
Company
Piscataway, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 53 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Appco Pharma LLC has 4 FDA actions in our database, including 4 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Appco Pharma LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Appco Pharma LLC have FDA actions?
Appco Pharma LLC has 4 FDA actions in our database, including 4 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0420-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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