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Heritage Pharmaceuticals Recalls
23 recalls on record · March 25, 2015 to August 19, 2026 · Drugs
Recalls by year
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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.
August 19, 2026DrugsFDA
Heritage Pharmaceuticals Inc recalls CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceut
Hazard: Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
November 5, 2025DrugsFDA
Heritage Pharmaceuticals Inc recalls Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Privat
Hazard: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
November 5, 2025DrugsFDA
Heritage Pharmaceuticals Inc recalls Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Priva
Hazard: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
November 5, 2025DrugsFDA
Heritage Pharmaceuticals Inc recalls Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Privat
Hazard: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
November 5, 2025DrugsFDA
Heritage Pharmaceuticals Inc recalls Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Privat
Hazard: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
November 5, 2025DrugsFDA
Heritage Pharmaceuticals Inc recalls Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Privat
Hazard: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
November 5, 2025DrugsFDA
Heritage Pharmaceuticals Inc recalls Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Priv
Hazard: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.
December 7, 2022DrugsFDA
Heritage Pharmaceuticals Inc recalls Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick
Hazard: Subpotent Drug
May 12, 2021DrugsFDA
Heritage Pharmaceuticals Inc recalls Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 0881
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date
December 2, 2020DrugsFDA
Heritage Pharmaceuticals Inc recalls Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc.
Hazard: Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A
June 19, 2019DrugsFDA
Heritage Pharmaceuticals, Inc. recalls AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hin
Hazard: Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
June 19, 2019DrugsFDA
Heritage Pharmaceuticals, Inc. recalls PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hi
Hazard: Non-Sterility:Microbial growth detected in sub lot of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) .
May 29, 2019DrugsFDA
Heritage Pharmaceuticals, Inc. recalls Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Li
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
May 29, 2019DrugsFDA
Heritage Pharmaceuticals, Inc. recalls Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Privat
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
May 29, 2019DrugsFDA
Heritage Pharmaceuticals, Inc. recalls Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, P
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
May 29, 2019DrugsFDA
Heritage Pharmaceuticals, Inc. recalls Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, P
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
May 29, 2019DrugsFDA
Heritage Pharmaceuticals, Inc. recalls Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private L
Hazard: CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
March 27, 2019DrugsFDA
Heritage Pharmaceuticals, Inc. recalls Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals
Hazard: Subpotent Drug.
January 16, 2019DrugsFDA
Heritage Pharmaceuticals, Inc. recalls Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjaw
Hazard: Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle
October 31, 2018DrugsFDA
Heritage Pharmaceuticals, Inc. recalls Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawad
Hazard: Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
April 15, 2015DrugsFDA
Heritage Pharmaceuticals, Inc. recalls GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage
Hazard: Failed Impurities/Degradation Specifications: Out of specification for unknown impurity.
March 25, 2015DrugsFDA
Heritage Pharmaceuticals, Inc. recalls RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, In
Hazard: Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.
March 25, 2015DrugsFDA
Heritage Pharmaceuticals, Inc. recalls Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pun
Hazard: Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.