Heritage Pharmaceuticals Inc

FDA Regulatory Profile

Heritage Pharmaceuticals Inc appears in FDA public data with 23 recalls — including 2 Class I (most serious) —, 0 510(k) clearances, 13 FDA inspections, and 1 compliance action on record. Its most recent recall (D-0768-2026, Class II) was initiated on Jul 30, 2026.

Summary

Total Recalls
23 (2 Class I)
510(k) Clearances
0
Inspections
13
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0768-2026Class IICLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, DistributedJul 30, 2026
D-0109-2026Class IIDesipramine Hydrochloride Tablets, USP, 50 mg, 100 count bottle (NDC 23155-580-01), Rx only, ManufacOct 6, 2025
D-0110-2026Class IIDesipramine Hydrochloride Tablets, USP, 75 mg, 100 count bottle (NDC 23155-581-01), Rx only, ManufacOct 6, 2025
D-0108-2026Class IIDesipramine Hydrochloride Tablets, USP, 25 mg, 100 count bottle (NDC 23155-579-01), Rx only, ManufacOct 6, 2025
D-0111-2026Class IIDesipramine Hydrochloride Tablets, USP, 100 mg, 100 count bottle (NDC 23155-582-01), Rx only, ManufaOct 6, 2025
D-0112-2026Class IIDesipramine Hydrochloride Tablets, USP, 150 mg, 50 count bottle (NDC 23155-583-25), Rx only, ManufacOct 6, 2025
D-0107-2026Class IIDesipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, ManufOct 6, 2025
D-0072-2023Class IIDesmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet PharmaceuticalsNov 23, 2022
D-0367-2021Class IIIAcyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., EasApr 21, 2021
D-0108-2021Class IIIFelodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage POct 23, 2020
D-1397-2019Class IPROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure PharMay 21, 2019
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-1287-2019Class IILosartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed LifMay 3, 2019
D-1288-2019Class IILosartan Potassium Tablets USP 100 mg 90 film coated tablets Manufactured by: Vivimed Life ScienceMay 3, 2019
D-1289-2019Class IILosartan Potassium Tablets USP 50 mg 90 film coated tablets Manufactured by: Vivimed Life ScienceMay 3, 2019
D-1290-2019Class IILosartan Potassium Tablets USP 100 mg 1000 film coated tablets Rx only Manufactured by: Vivimed May 3, 2019
D-1291-2019Class IILosartan Potassium Tablets USP 25 mg 90 film coated tablets Rx Only Manufactured by: Vivimed LifeMay 3, 2019
D-1065-2019Class IIEtomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: HeriFeb 15, 2019
D-0352-2019Class IICidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure PharmaceJan 2, 2019
D-0094-2019Class IICidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure PharmacOct 15, 2018