Heritage Pharmaceuticals recalls
Heritage Pharmaceuticals appears in 23 official U.S. recall notices indexed by RecallRadar, most recently on 2026-08-19.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 23 |
|---|---|
| Published | 2015-03-25 to 2026-08-19 |
| By agency | FDA Drug (23) |
| By classification | Class II (19), Class I (2), Class III (2) |
| By status | terminated (16), ongoing (7) |
| Distribution named in notices | OH, US |
Recalls
- CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Br…
FDA Drug · Class II · 2026-08-19 · Heritage Pharmaceuticals
Reason: Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles. - Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, Manufactured by: USV Private Limited, Daman, I…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals
Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. - Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, Manufactured by: USV Private Limited, Daman, I…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals
Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. - Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, Manufactured by: USV Private Limited, Daman, I…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals
Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. - Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, Manufactured by: USV Private Limited, Daman,…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals
Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. - Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, Manufactured by: USV Private Limited, Daman, I…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals
Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. - Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Private Limited, Daman,…
FDA Drug · Class II · 2025-11-05 · Heritage Pharmaceuticals
Reason: CGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level. - Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc
FDA Drug · Class II · 2022-12-07 · Heritage Pharmaceuticals
Reason: Subpotent Drug - Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-227-01
FDA Drug · Class III · 2021-05-12 · Heritage Pharmaceuticals
Reason: Labeling: Incorrect or Missing Lot and/or Exp Date - Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc
FDA Drug · Class III · 2020-12-02 · Heritage Pharmaceuticals
Reason: Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A - AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India…
FDA Drug · Class I · 2019-06-19 · Heritage Pharmaceuticals
Reason: 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) . - PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India
FDA Drug · Class I · 2019-06-19 · Heritage Pharmaceuticals
Reason: 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) . - Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101…
FDA Drug · Class II · 2019-05-29 · Heritage Pharmaceuticals
Reason: 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 - Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 1…
FDA Drug · Class II · 2019-05-29 · Heritage Pharmaceuticals
Reason: 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 - Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107…
FDA Drug · Class II · 2019-05-29 · Heritage Pharmaceuticals
Reason: 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 - Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101…
FDA Drug · Class II · 2019-05-29 · Heritage Pharmaceuticals
Reason: 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 - Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107…
FDA Drug · Class II · 2019-05-29 · Heritage Pharmaceuticals
Reason: 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 - Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals Inc
FDA Drug · Class II · 2019-03-27 · Heritage Pharmaceuticals
Reason: Subpotent Drug. - Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mf…
FDA Drug · Class II · 2019-01-16 · Heritage Pharmaceuticals
Reason: Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle - Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg
FDA Drug · Class II · 2018-10-31 · Heritage Pharmaceuticals
Reason: Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle - GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only
FDA Drug · Class II · 2015-04-15 · Heritage Pharmaceuticals
Reason: Failed Impurities/Degradation Specifications: Out of specification for unknown impurity. - Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufacture…
FDA Drug · Class II · 2015-03-25 · Heritage Pharmaceuticals
Reason: Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes. - RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmaceuticals Ltd., Hinjwadi, Pune, India Manufactured for:…
FDA Drug · Class II · 2015-03-25 · Heritage Pharmaceuticals
Reason: Lack of Assurance of Sterility: Firm is recalling two injectable products due to concerns with quality control processes.