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The Harvard Drug Group Recalls
55 recalls on record · February 4, 2015 to July 1, 2026 · Drugs, Food & Beverage
Recalls by year
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25
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
Also filed under
The recall feeds record what looks like the same company under more than one name:
July 1, 2026DrugsFDA
The Harvard Drug Group LLC recalls Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distribut
Hazard: Subpotent Drug
April 29, 2026DrugsFDA
The Harvard Drug Group LLC recalls Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Pac
Hazard: Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
April 22, 2026DrugsFDA
The Harvard Drug Group LLC recalls Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Di
Hazard: Failed Dissolution Specifications
March 11, 2026DrugsFDA
The Harvard Drug Group LLC recalls Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Maj
Hazard: Defective container; inadequately sealed blister packaging.
October 29, 2025DrugsFDA
The Harvard Drug Group LLC recalls Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmac
Hazard: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
October 29, 2025DrugsFDA
The Harvard Drug Group LLC recalls Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Phar
Hazard: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
July 9, 2025DrugsFDA
The Harvard Drug Group LLC recalls Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICAL
Hazard: Defective container; blister packaging inadequately sealed.
July 9, 2025DrugsFDA
The Harvard Drug Group LLC recalls Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJO
Hazard: Defective container; blister packaging inadequately sealed.
July 5, 2023DrugsFDA
The Harvard Drug Group recalls Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Indu
Hazard: Packaging defect: blister packaging inadequately sealed.
May 17, 2023DrugsFDA
The Harvard Drug Group recalls Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distribu
Hazard: Product mixup: one foreign tablet found in product.
March 8, 2023DrugsFDA
The Harvard Drug Group recalls Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Te
Hazard: Packaging defect: observed packaging defect, blister packaging inadequately sealed.
March 23, 2022DrugsFDA
The Harvard Drug Group recalls hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMA
Hazard: Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
March 16, 2022DrugsFDA
The Harvard Drug Group recalls PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: S
Hazard: Failed Dissolution Specifications
December 29, 2021DrugsFDA
The Harvard Drug Group recalls Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laure
Hazard: Failed Impurities/Degradation Specifications
September 29, 2021DrugsFDA
The Harvard Drug Group recalls Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals
Hazard: Failed Dissolution Specifications
September 29, 2021DrugsFDA
The Harvard Drug Group recalls Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177
Hazard: Failed Dissolution Specifications
July 21, 2021DrugsFDA
The Harvard Drug Group recalls NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 5
Hazard: Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
December 9, 2020DrugsFDA
The Harvard Drug Group recalls Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontar
Hazard: Failed Dissolution Specifications: Out of specification for dissolution.
July 8, 2020DrugsFDA
The Harvard Drug Group recalls Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufac
Hazard: CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
June 10, 2020DrugsFDA
The Harvard Drug Group recalls Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit do
Hazard: Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
May 20, 2020DrugsFDA
The Harvard Drug Group recalls Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by:
Hazard: Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
March 18, 2020DrugsFDA
The Harvard Drug Group recalls Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin
Hazard: Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
March 18, 2020DrugsFDA
The Harvard Drug Group recalls Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin
Hazard: Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
March 18, 2020DrugsFDA
The Harvard Drug Group recalls Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin
Hazard: Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
March 18, 2020DrugsFDA
The Harvard Drug Group recalls Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin L
Hazard: Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
February 26, 2020DrugsFDA
The Harvard Drug Group recalls Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured
Hazard: Failed Dissolution Specifications: High out of specification result observed at stability studies.
October 25, 2017DrugsFDA
The Harvard Drug Group recalls Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma Privat
Hazard: Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
September 20, 2017Food & BeverageFDA
The Harvard Drug Group recalls Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL)
Hazard: The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
September 20, 2017Food & BeverageFDA
The Harvard Drug Group recalls Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (50 mL)
Hazard: The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.
September 20, 2017Food & BeverageFDA
The Harvard Drug Group recalls Major Tri-Vita Drops, 1 2/3 oz (50 mL)
Hazard: The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.