DrugJul 5, 2023
The Harvard Drug Group Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count recall — FDA D-0878-2023
Packaging defect: blister packaging inadequately sealed.
Class IIFDA: TerminatedThe Harvard Drug Group
Recall history in this database
Classification mix: Class II: 34, Class III: 7.
DrugMay 17, 2023
Gabapentin Tablets, USP 600 mg recall — FDA D-0570-2023
Product mixup: one foreign tablet found in product.
Class IIIFDA: TerminatedThe Harvard Drug Group
DrugMar 8, 2023
The Harvard Drug Group Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose recall — FDA D-0432-2023
Packaging defect: observed packaging defect, blister packaging inadequately sealed.
Class IIFDA: TerminatedThe Harvard Drug Group
DrugMar 23, 2022
The Harvard Drug Group hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton recall — FDA D-0653-2022
Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
Class IIFDA: TerminatedThe Harvard Drug Group
DrugMar 16, 2022
PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs) recall — FDA D-0649-2022
Failed Dissolution Specifications
Class IIFDA: TerminatedThe Harvard Drug Group
DrugSep 29, 2021
Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons recall — FDA D-0807-2021
Failed Dissolution Specifications
Class IIFDA: TerminatedThe Harvard Drug Group
DrugJul 21, 2021
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg recall — FDA D-0652-2021
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Class IIFDA: TerminatedThe Harvard Drug Group
DrugDec 9, 2020
The Harvard Drug Group Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton recall — FDA D-0114-2021
Failed Dissolution Specifications: Out of specification for dissolution.
Class IIFDA: TerminatedThe Harvard Drug Group
DrugJul 8, 2020
The Harvard Drug Group Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 recall — FDA D-1360-2020
CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
Class IIFDA: TerminatedThe Harvard Drug Group
DrugJun 10, 2020
The Harvard Drug Group Doxycycline Hyclate Tablets, USP, 100 mg recall — FDA D-1288-2020
Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
Class IIFDA: TerminatedThe Harvard Drug Group
DrugMay 20, 2020
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons recall — FDA D-1262-2020
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Class IIIFDA: TerminatedThe Harvard Drug Group
DrugMar 18, 2020
Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton recall — FDA D-1000-2020
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class IIIFDA: TerminatedThe Harvard Drug Group
DrugMar 18, 2020
Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton recall — FDA D-1002-2020
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class IIIFDA: TerminatedThe Harvard Drug Group
DrugMar 18, 2020
Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton recall — FDA D-1001-2020
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class IIIFDA: TerminatedThe Harvard Drug Group
DrugMar 18, 2020
Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton recall — FDA D-0999-2020
Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Class IIIFDA: TerminatedThe Harvard Drug Group
DrugFeb 26, 2020
Memantine Hydrochloride Extended-release Capsules, 28mg recall — FDA D-0844-2020
Failed Dissolution Specifications: High out of specification result observed at stability studies.
Class IIIFDA: TerminatedThe Harvard Drug Group
DrugOct 25, 2017
The Harvard Drug Group Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per recall — FDA D-0013-2018
Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
Class IIFDA: TerminatedThe Harvard Drug Group
FoodSep 20, 2017
The Harvard Drug Group Major Ferrous Drops, 1 2/3 oz recall — FDA F-3526-2017
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…
Class IIFDA: TerminatedThe Harvard Drug Group
FoodSep 20, 2017
The Harvard Drug Group Major CertaVite Liquid, 8 oz recall — FDA F-3524-2017
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…
Class IIFDA: TerminatedThe Harvard Drug Group
FoodSep 20, 2017
The Harvard Drug Group Rugby Tri-vitamin Liquid, 1 2/3 oz recall — FDA F-3523-2017
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…
Class IIFDA: TerminatedThe Harvard Drug Group
FoodSep 20, 2017
The Harvard Drug Group Major Poly-Vita Drops, 1 2/3 oz recall — FDA F-3527-2017
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…
Class IIFDA: TerminatedThe Harvard Drug Group
FoodSep 20, 2017
The Harvard Drug Group Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL recall — FDA F-3518-2017
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…
Class IIFDA: TerminatedThe Harvard Drug Group
FoodSep 20, 2017
The Harvard Drug Group Leader Liquid Multivitamin Supplement for Infants and Toddlers recall — FDA F-3530-2017
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…
Class IIFDA: TerminatedThe Harvard Drug Group
FoodSep 20, 2017
The Harvard Drug Group Rugby Polyvitamin Liquid with Iron, 1 2/3 oz recall — FDA F-3522-2017
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…
Class IIFDA: TerminatedThe Harvard Drug Group
Understanding this recall history
This page summarizes recall records in which the official source identifies The Harvard Drug Group as the recalling firm or manufacturer. The number of records should not be treated as a safety rating or a measure of company size, because recall counts depend on product mix, reporting periods and how government records are organized.
Compare the dates, categories and classifications together rather than relying on the total alone. Open an individual record for the recalled product, reason, distribution details and current instructions available from the source.