Reported Apr 8, 2026 · Ongoing
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,…
Appco Pharma LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Appco Pharma LLC · 262 Old New Brunswick Rd Ste N · Piscataway, NJ · 08854-3888
Is this the product you have?
- Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only
- Manufactured forBiocon Pharma Inc., Iselin, NJ
- Manufactured byAppco Pharma LLC, Piscataway, NJ, NDC 70377-068-11
- Lot codes and dates
- Lot
2406255UCExp.: 2026/MAY2406256UCExp.: 2026/JUL2407313UC Exp.: 2026/JUL2408351UCExp.: 2026/JUL2408352UCExp.: 2026/JUL2509311UCExp.: 2027/SEP
- Lot
- Amount recalled
- 28,157 bottles- 100's count
This recall covers 3 products
The agency filed one notice per product. You are reading one of them; the other 2 are below.
Where it was sold
- Nationwide
Why it was recalled
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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