The Harvard Drug Group LLC

FDA Regulatory Profile

Summary

Total Recalls
52 (1 Class I)
510(k) Clearances
0
Inspections
3
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0383-2026Class IIMidodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged andFebruary 17, 2026
D-0031-2026Class IIGabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and DistributOctober 10, 2025
D-0030-2026Class IIGabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and DistriOctober 10, 2025
D-0507-2025Class IIGabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and June 19, 2025
D-0508-2025Class IIGabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: June 19, 2025
D-0878-2023Class IITramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: SunJune 16, 2023
D-0570-2023Class IIIGabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10April 24, 2023
D-0432-2023Class IICarbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in CFebruary 23, 2023
D-0649-2022Class IIPALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx onlyFebruary 28, 2022
D-0653-2022Class IIhydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, DistribuFebruary 24, 2022
D-0807-2021Class IICarbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: TorAugust 6, 2021
D-0289-2022Class IIFexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major PharmaceutiAugust 3, 2021
D-0806-2021Class IIEntacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major PhJuly 29, 2021
D-0652-2021Class IINIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDJuly 2, 2021
D-0114-2021Class IIAripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex,November 18, 2020
D-1360-2020Class IIMetformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartoJune 12, 2020
D-1288-2020Class IIDoxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) aMay 22, 2020
D-1262-2020Class IIIMemantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx onlApril 24, 2020
D-1001-2020Class IIIQuetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, ManFebruary 27, 2020
D-0999-2020Class IIIQuetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, ManuFebruary 27, 2020