Piscataway, NJ, United States
Appco Pharma LLC recalls
3 recalls recorded since 2018, most recently on 27 March 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls3
Ongoing (FDA)1
Terminated or completed2
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 27 March 2026
- Reason
- cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0419-2026, D-0420-2026, D-0421-2026
- Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ, Manufactured by: Appco Pharma LLC, Piscataway, NJ, NDC 70377-066-11.
- 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.
- 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.
Completed Class III Drugs
- Recall started
- 16 January 2025
- Reason
- Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
- Distribution
- Nationwide USA.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0208-2025
- Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Terminated Class II Drugs
- Recall started
- 7 January 2020
- Terminated
- 24 April 2020
- Reason
- CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
- Distribution
- Product was distributed to 6 major distributors/wholesalers some with multiple locations who may have further distribute the product.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0648-2020, D-0649-2020
- Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
- Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc.,
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.