Heritage Pharmaceuticals recalls
FDA enforcement reports naming Heritage Pharmaceuticals Inc as the recalling firm.
- Recall reports
- 23
- Class I (serious)
- 2
- Most recent report
- Aug 19, 2026
- Aug 19, 2026CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL…Drug · Heritage Pharmaceuticals IncPresence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.Class II
- Nov 5, 2025Desipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx…Drug · Heritage Pharmaceuticals IncCGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.Class II
- Nov 5, 2025Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), R…Drug · Heritage Pharmaceuticals IncCGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.Class II
- Nov 5, 2025Desipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx…Drug · Heritage Pharmaceuticals IncCGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.Class II
- Nov 5, 2025Desipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx…Drug · Heritage Pharmaceuticals IncCGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.Class II
- Nov 5, 2025Desipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx…Drug · Heritage Pharmaceuticals IncCGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.Class II
- Nov 5, 2025Desipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx…Drug · Heritage Pharmaceuticals IncCGMP Deviations: N-Nitroso Desipramine impurity exceeding the permissible acceptable daily intake level.Class II
- Dec 7, 2022Desmopressin Acetate Tablets 0Drug · Heritage Pharmaceuticals IncSubpotent DrugClass II
- May 12, 2021Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceutic…Drug · Heritage Pharmaceuticals IncLabeling: Incorrect or Missing Lot and/or Exp DateClass III
- Dec 2, 2020Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed b…Drug · Heritage Pharmaceuticals IncFailed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound AClass III
- PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by…
- AMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd
- Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by:…
- Losartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed…
- Losartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured…
- Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by…
- Losartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed…
- Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactu…
- Cidofovir Injection 375mg/5mL (75mg/mL) vial injection
- Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg
- GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2
- Colistimethate for Injection USP, 150 mg per vial, Rx Only, Manufactured by: Emcure Ph…
- RIFAMPIN for Injection,USP, 600 mg per vial, Rx Only, Manufactured by: Emcure Pharmac…
Page 1 of 3