Why it was recalled
cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
Product description
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.
Lot numbers, UPCs & expiration codes
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. .
Where it was sold
U.S.A. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0421-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 27, 2026
- FDA report date
- Apr 8, 2026
- Quantity
- 28,157 bottles- 100's count
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Appco Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0421-2026, exactly as published.
Show all FDA fields
- City
- Piscataway
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98658
- Address
- 262 Old New Brunswick Rd Ste N
- Code information
- 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. .
- Postal code
- 08854-3888
- Report date
- Apr 8, 2026
- Product type
- Drugs
- Recall number
- D-0421-2026
- Classification
- Class II
- Recalling firm
- Appco Pharma LLC
- Product quantity
- 28,157 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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.
- Distribution pattern
- U.S.A. Nationwide
- Recall initiation date
- Mar 27, 2026
- Initial firm notification
- Center classification date
- Mar 31, 2026