Home / Recalls / Appco Pharma LLC / D-0420-2026

D-0420-2026 Class II Ongoing

Recalled by Appco Pharma LLC — Piscataway, NJ

Recall Details

Product Type
Drugs
Report Date
April 8, 2026
Initiation Date
March 27, 2026
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
58,896 bottles- 100's count

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.

Reason for Recall

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

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot:2404153UC, Exp.: 2026/MAR; 2404154UC, Exp.:2026/MAR; 2502055UC, Exp.: 2027/JAN; 2505173UC, Exp.: 2027/MAY; 2505175UC, Exp.: 2027/MAY.

Other recalls by Appco Pharma LLC

  • D-0419-2026 Class II — Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactur (March 27, 2026)
  • D-0421-2026 Class II — Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactur (March 27, 2026)
  • D-0208-2025 Class III — Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured b (January 16, 2025)
  • D-0649-2020 Class II — Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 co (January 7, 2020)
  • D-0648-2020 Class II — Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Ph (January 7, 2020)