Recalls / Class II
Class IID-0421-2026
Product
Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-068-11.
- Brand name
- Prazosin Hydrochloride
- Generic name
- Prazosin Hydrochloride
- Active ingredient
- Prazosin Hydrochloride
- Route
- Oral
- NDCs
- 70377-066, 70377-067, 70377-068
- FDA application
- ANDA213406
- Affected lot / code info
- Lot:2406255UC, Exp.: 2026/MAY; 2406256UC, Exp.: 2026/JUL; 2407313UC Exp.: 2026/JUL; 2408351UC, Exp.: 2026/JUL; 2408352UC , Exp.: 2026/JUL; 2509311UC, Exp.: 2027/SEP. .
Why it was recalled
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Recalling firm
- Firm
- Appco Pharma LLC
- Manufacturer
- Biocon Pharma Inc.
- Notification channel
- Type
- Voluntary: Firm initiated
- Address
- 262 Old New Brunswick Rd Ste N, Piscataway, New Jersey 08854-3888
Distribution
- Quantity
- 28,157 bottles- 100's count
- Distribution pattern
- U.S.A. Nationwide
Timeline
- Recall initiated
- 2026-03-27
- FDA classified
- 2026-03-31
- Posted by FDA
- 2026-04-08
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0421-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.