Heritage Pharmaceuticals, Inc.

FDA Regulatory Profile

Summary

Total Recalls
22 (2 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0108-2026Class IIDesipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, ManufacOctober 6, 2025
D-0112-2026Class IIDesipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, ManufacOctober 6, 2025
D-0110-2026Class IIDesipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, ManufacOctober 6, 2025
D-0107-2026Class IIDesipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, ManufOctober 6, 2025
D-0111-2026Class IIDesipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, ManufaOctober 6, 2025
D-0109-2026Class IIDesipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, ManufacOctober 6, 2025
D-0072-2023Class IIDesmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet PharmaceuticalsNovember 23, 2022
D-0367-2021Class IIIAcyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., EasApril 21, 2021
D-0108-2021Class IIIFelodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage POctober 23, 2020
D-1398-2019Class IAMIKACIN SULFATE INJECTION, USP, 1 gram/4 mL (250 mg/ml), 4 mL vial, Rx only, Mfd. by: Emcure PharmaMay 21, 2019
D-1397-2019Class IPROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure PharMay 21, 2019
D-1290-2019Class IILosartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed May 3, 2019
D-1289-2019Class IILosartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life ScienceMay 3, 2019
D-1288-2019Class IILosartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life ScienceMay 3, 2019
D-1291-2019Class IILosartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed LifeMay 3, 2019
D-1287-2019Class IILosartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed LifMay 3, 2019
D-1065-2019Class IIEtomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: HeriFebruary 15, 2019
D-0352-2019Class IICidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure PharmaceJanuary 2, 2019
D-0094-2019Class IICidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure PharmacOctober 15, 2018
D-0436-2015Class IIGLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. ManufacMarch 25, 2015