Livonia, MI, United States
The Harvard Drug Group recalls
21 recalls recorded since 2018, most recently on 16 June 2026. 6 are listed as ongoing. Status and classification are as published by the FDA.
Recalls21
Ongoing (FDA)6
Terminated or completed15
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 16 June 2026
- Reason
- Subpotent Drug
- Distribution
- U.S. Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0609-2026
- Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, in 46268, NDC 0904-7282-10. Blister Label: Methylergono
Ongoing Class II Drugs
- Recall started
- 9 April 2026
- Reason
- Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
- Distribution
- Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0493-2026
- Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46288. NDC: 0904-7495-06
Ongoing Class II Drugs
- Recall started
- 24 March 2026
- Reason
- Failed Dissolution Specifications
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0485-2026
- Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, NDC 0904-6734-61
Ongoing Class II Drugs
- Recall started
- 17 February 2026
- Reason
- Defective container; inadequately sealed blister packaging.
- Distribution
- Nationwide US.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0383-2026
- Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268 USA, NDC 0904-6818-06.
Ongoing Class II Drugs
- Recall started
- 10 October 2025
- Reason
- Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
- Distribution
- US Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0031-2026, D-0030-2026
- Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61 (Blister pack), NDC 55154-3363-0 (Outer Bag)
- Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapolis, IN 46268, USA, NDC 0904-6665-61
Ongoing Class II Drugs
- Recall started
- 19 June 2025
- Reason
- Defective container; blister packaging inadequately sealed.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0507-2025, D-0508-2025
- Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, NDC 0904-6665-61
- Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN, 46268 USA, Distributed by Cardinal Health, Dublin, OH 43017, NDC 55154-3363-0
Terminated Class II Drugs
- Recall started
- 16 June 2023
- Terminated
- 30 April 2024
- Reason
- Packaging defect: blister packaging inadequately sealed.
- Distribution
- Nationwide in the U.S.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0878-2023
- Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd. Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), India. Distributed by: Sun Pharmaceu
Terminated Class III Drugs
- Recall started
- 24 April 2023
- Terminated
- 30 April 2024
- Reason
- Product mixup: one foreign tablet found in product.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0570-2023
- Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo Pharma USA, Inc. East Windsor, NJ 08520 Distributed by: Major Pharmaceuticals 1717
Terminated Class II Drugs
- Recall started
- 23 February 2023
- Terminated
- 30 April 2024
- Reason
- Packaging defect: observed packaging defect, blister packaging inadequately sealed.
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0432-2023
- Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries, s.r.o. Opava-Komarov, Czech Republic, Manufactured for: Teva Pharmaceuticals US
Terminated Class II Drugs
- Recall started
- 28 February 2022
- Terminated
- 8 June 2023
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0649-2022
- PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PH
Terminated Class II Drugs
- Recall started
- 24 February 2022
- Terminated
- 16 July 2023
- Reason
- Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
- Distribution
- Nationwide within USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0653-2022
- hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia, MI 48152 USA. NDC # 0904-6440-61
Terminated Class II Drugs
- Recall started
- 6 August 2021
- Terminated
- 8 November 2022
- Reason
- Failed Dissolution Specifications
- Distribution
- NC
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0807-2021
- Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-392130, India; Manufactured for: Torrent Pharma, Inc., Basking Ridge, NJ 07920; Distr
Terminated Class II Drugs
- Recall started
- 3 August 2021
- Terminated
- 16 July 2023
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0289-2022
- Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite 233, Livonia, MI 48152 NDC 0904-6979-40
Terminated Class II Drugs
- Recall started
- 29 July 2021
- Terminated
- 19 February 2023
- Reason
- Failed Dissolution Specifications
- Distribution
- CO, FL, MO, OH
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0806-2021
- Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC 0904-6822-04
Terminated Class II Drugs
- Recall started
- 2 July 2021
- Terminated
- 28 December 2022
- Reason
- Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
- Distribution
- Distributed in OH and NJ
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0652-2021
- NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b) 50 count unit dose carton, NDC 0904-7080-06: Distributed by: Ingenus Pharmaceuticals, LLC Orlando, FL
Terminated Class II Drugs
- Recall started
- 18 November 2020
- Terminated
- 19 February 2023
- Reason
- Failed Dissolution Specifications: Out of specification for dissolution.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0114-2021
- Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livon
Terminated Class II Drugs
- Recall started
- 12 June 2020
- Terminated
- 24 September 2022
- Reason
- CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1360-2020
- Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, Inc., Toronto, Ontario, Canada, Manufactured for: Apotex Corp. Weston, FL, Distrib
Terminated Class II Drugs
- Recall started
- 22 May 2020
- Terminated
- 2 October 2022
- Reason
- Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1288-2020
- Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit dose carton (NDC 0904-0430-06), Mfd. by: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724; Distribu
Terminated Class III Drugs
- Recall started
- 24 April 2020
- Terminated
- 19 August 2022
- Reason
- Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
- Distribution
- AL, FL, IA, NY, OH, TX
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1262-2020
- Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laure
Terminated Class III Drugs
- Recall started
- 27 February 2020
- Terminated
- 24 September 2022
- Reason
- Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1000-2020, D-1002-2020, D-1001-2020, D-0999-2020
- Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park
- Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park
- Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park
- Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454775 India; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park D
Terminated Class III Drugs
- Recall started
- 13 December 2019
- Terminated
- 4 November 2020
- Reason
- Failed Dissolution Specifications: High out of specification result observed at stability studies.
- Distribution
- U.S.A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0844-2020
- Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 United States; Distributed by: Major
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.