Appco Pharma Recalls
6 recalls on record · January 15, 2020 to April 8, 2026 · Drugs
Recalls by year
20
25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 8, 2026DrugsFDA
Appco Pharma LLC recalls Prazosin Hydrochloride Capsules, USP, 5mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,
Hazard: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
April 8, 2026DrugsFDA
Appco Pharma LLC recalls Prazosin Hydrochloride Capsules, USP, 2mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,
Hazard: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
April 8, 2026DrugsFDA
Appco Pharma LLC recalls Prazosin Hydrochloride Capsules, USP, 1mg, 100-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ,
Hazard: cGMP deviation: detection of Nitrosamine Drug Substance-Related Impurities, N-nitroso-prazosin impurity C (NNP) above acceptable limits.
January 29, 2025DrugsFDA
Appco Pharma LLC recalls Venlafaxine Extended-Release Tablets, 150mg, Rx only, 90 Tablets, Manufactured by Appco Pharma. LLC, NDC 43598-943-90.
Hazard: Failed Tablet/Capsule Specifications: Missing tab ID on either side of the tablet
January 15, 2020DrugsFDA
Appco Pharma LLC recalls Ranitidine Capsules 150 mg, (a) 60 count bottles (NDC 62559-690-60) , (b) 500 count bottles (NDC 62559-690-05), Rx only,
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API
January 15, 2020DrugsFDA
Appco Pharma LLC recalls Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distribu
Hazard: CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API