The Harvard Drug Group Provisional
FDA Flags (16)
Class II RecallJul 2026
The Harvard Drug Group LLC
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distribut
Classification: Class II
Class II RecallApr 2026
The Harvard Drug Group LLC
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Pac
Classification: Class II
Class II RecallApr 2026
The Harvard Drug Group LLC
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Di
Classification: Class II
Class II RecallMar 2026
The Harvard Drug Group LLC
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Maj
Classification: Class II
Class II RecallOct 2025
The Harvard Drug Group LLC
Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmac
Classification: Class II
Class II RecallOct 2025
The Harvard Drug Group LLC
Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Phar
Classification: Class II
Class II RecallJul 2025
The Harvard Drug Group LLC
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJO
Classification: Class II
Class II RecallJul 2025
The Harvard Drug Group LLC
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICAL
Classification: Class II
Class II RecallJul 2023
The Harvard Drug Group
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Indu
Classification: Class II
Class III RecallMay 2023
The Harvard Drug Group
Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distribu
Classification: Class III
Class II RecallMar 2023
The Harvard Drug Group
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Te
Classification: Class II
Class II RecallMar 2022
The Harvard Drug Group
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMA
Classification: Class II
Class II RecallMar 2022
The Harvard Drug Group
PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: S
Classification: Class II
Class II RecallDec 2021
The Harvard Drug Group
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laure
Classification: Class II
Class II RecallSep 2021
The Harvard Drug Group
Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals
Classification: Class II
Class II RecallSep 2021
The Harvard Drug Group
Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177
Classification: Class II