The Harvard Drug Group recalls

The Harvard Drug Group appears in 79 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-01.

Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.

Recall summary

Recall notices	79
Published	2015-02-04 to 2026-07-01
By agency	FDA Drug (61), FDA Food (18)
By classification	Class II (63), Class III (11), Class I (5)
By status	terminated (58), ongoing (21)
Distribution named in notices	AL, AZ, CA, CO, CT, FL, GA, IA, IL, KY, MA, MI, MO, MS, NC, NE, NJ, NY, OH, OR, PA, TN, TX, US, UT, VA, WA, WI, WV

Recalls

Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and Distributed by: MAJOR PHARMA…
FDA Drug · Class II · 2026-07-01 · The Harvard Drug Group
Reason: Subpotent Drug
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only, Packaged and Distribut…
FDA Drug · Class II · 2026-04-29 · The Harvard Drug Group
Reason: Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major…
FDA Drug · Class II · 2026-04-22 · The Harvard Drug Group
Reason: Failed Dissolution Specifications
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals,…
FDA Drug · Class II · 2026-03-11 · The Harvard Drug Group
Reason: Defective container; inadequately sealed blister packaging.
Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indian…
FDA Drug · Class II · 2025-10-29 · The Harvard Drug Group
Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged and Distributed by: Major Pharmaceuticals, Indianapo…
FDA Drug · Class II · 2025-10-29 · The Harvard Drug Group
Reason: Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
Major ChlorproMAZINE Hydrochloride Tablets, USP, 100 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Ph…
FDA Drug · Class II · 2025-10-15 · The Harvard Drug Group
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Pha…
FDA Drug · Class II · 2025-10-15 · The Harvard Drug Group
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and Distributed by Major Pharm…
FDA Drug · Class II · 2025-10-15 · The Harvard Drug Group
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Major ChlorproMAZINE Hydrochloride Tablets, USP, 50 mg, 100 Tablets, (10x10) blister package, Rx Only, Packaged and Distributed by Major Ph…
FDA Drug · Class II · 2025-10-15 · The Harvard Drug Group
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Major ChlorproMAZINE Hydrochloride Tablets, USP, 200 mg, 100 Tablets (10x10) blister package, Rx Only, Packaged and Distributed by Major Ph…
FDA Drug · Class II · 2025-10-15 · The Harvard Drug Group
Reason: CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per carton, Rx only, Pa…
FDA Drug · Class II · 2025-09-17 · The Harvard Drug Group
Reason: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was d…
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 10 Tablets unit dose blister pack (10x1) per bag, Rx only, Distribu…
FDA Drug · Class II · 2025-09-17 · The Harvard Drug Group
Reason: Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was d…
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major Pharmaceuticals, Indianapolis, I…
FDA Drug · Class II · 2025-08-27 · The Harvard Drug Group
Reason: CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS, Indianapolis, IN…
FDA Drug · Class II · 2025-07-09 · The Harvard Drug Group
Reason: Defective container; blister packaging inadequately sealed.
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by: MAJOR PHARMACEUTICALS,…
FDA Drug · Class II · 2025-07-09 · The Harvard Drug Group
Reason: Defective container; blister packaging inadequately sealed.
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and Distributed by: Major P…
FDA Drug · Class II · 2025-04-23 · The Harvard Drug Group
Reason: CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and Distributed by: Major Ph…
FDA Drug · Class III · 2025-04-09 · The Harvard Drug Group
Reason: Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this packa…
FDA Drug · Class II · 2025-02-26 · The Harvard Drug Group
Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lorazepam Tablets, USP, 1mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package…
FDA Drug · Class II · 2025-02-26 · The Harvard Drug Group
Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Lorazepam Tablets, USP, 2mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product contained in this package…
FDA Drug · Class II · 2025-02-26 · The Harvard Drug Group
Reason: Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for Assay and Impurities.
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters), Rx Only, Distribute…
FDA Drug · Class II · 2025-02-12 · The Harvard Drug Group
Reason: Failed Dissolution Specifications.
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and b) 100 Unit Doses (1…
FDA Drug · Class II · 2025-02-05 · The Harvard Drug Group
Reason: CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake limit
Guaifenesin Dextromethorphan Syrup, 100 mg/10mg per 5 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, NDC…
FDA Drug · Class II · 2024-11-27 · The Harvard Drug Group
Reason: Failed Impurity/Degradation Specifications
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100, Indianapolis, IN, 46268, ND…
FDA Drug · Class II · 2024-11-27 · The Harvard Drug Group
Reason: Failed Impurity/Degradation Specifications
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, D…
FDA Drug · Class III · 2024-11-20 · The Harvard Drug Group
Reason: Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by: Cadila Healthcare L…
FDA Drug · Class II · 2024-07-10 · The Harvard Drug Group
Reason: Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only, Manufactured for Heritage Ph…
FDA Drug · Class II · 2024-02-21 · The Harvard Drug Group
Reason: an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could cause a medically reversible or transient adverse health consequences.
Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per case (NDC 0904-7079-57)…
FDA Drug · Class I · 2023-12-27 · The Harvard Drug Group
Reason: Failed Content Uniformity Specifications
Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES, Livonia, MI 48152, NDC 05…
FDA Drug · Class I · 2023-11-29 · The Harvard Drug Group
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.5 FL OZ (15mL) bottles, Distributed by: RUGBY LABORATORIES, Li…
FDA Drug · Class I · 2023-11-29 · The Harvard Drug Group
Reason: Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd
FDA Drug · Class II · 2023-07-05 · The Harvard Drug Group
Reason: Packaging defect: blister packaging inadequately sealed.
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd
FDA Drug · Class I · 2023-06-28 · The Harvard Drug Group
Reason: Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and containing Dronabinol Capsules, USP, 2.5 mg.
Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only, Distributed by: Aurobindo P…
FDA Drug · Class III · 2023-05-17 · The Harvard Drug Group
Reason: Product mixup: one foreign tablet found in product.
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by: Teva Czech Industries…
FDA Drug · Class II · 2023-03-08 · The Harvard Drug Group
Reason: Packaging defect: observed packaging defect, blister packaging inadequately sealed.
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR PHARMACEUTICALS, Livonia,…
FDA Drug · Class II · 2022-03-23 · The Harvard Drug Group
Reason: Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical I…
FDA Drug · Class II · 2022-03-16 · The Harvard Drug Group
Reason: Failed Dissolution Specifications
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Drive, Suite…
FDA Drug · Class II · 2021-12-29 · The Harvard Drug Group
Reason: Failed Impurities/Degradation Specifications
Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufactured by: Torrent Pharmaceuticals Ltd., Bharuch-3921…
FDA Drug · Class II · 2021-09-29 · The Harvard Drug Group
Reason: Failed Dissolution Specifications
Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr.…
FDA Drug · Class II · 2021-09-29 · The Harvard Drug Group
Reason: Failed Dissolution Specifications
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61
FDA Drug · Class II · 2021-07-21 · The Harvard Drug Group
Reason: Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto, Ontario Canada M9L 1T9,…
FDA Drug · Class II · 2020-12-09 · The Harvard Drug Group
Reason: Failed Dissolution Specifications: Out of specification for dissolution.
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only, Manufactured by: Apotex, I…
FDA Drug · Class II · 2020-07-08 · The Harvard Drug Group
Reason: CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
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…
FDA Drug · Class II · 2020-06-10 · The Harvard Drug Group
Reason: Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pith…
FDA Drug · Class III · 2020-05-20 · The Harvard Drug Group
Reason: Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur…
FDA Drug · Class III · 2020-03-18 · The Harvard Drug Group
Reason: Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur (…
FDA Drug · Class III · 2020-03-18 · The Harvard Drug Group
Reason: Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur…
FDA Drug · Class III · 2020-03-18 · The Harvard Drug Group
Reason: Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin Limited, Pithampur…
FDA Drug · Class III · 2020-03-18 · The Harvard Drug Group
Reason: Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate Extended-Release Tablets.
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only, Manufactured for: Lupin Pharmac…
FDA Drug · Class III · 2020-02-26 · The Harvard Drug Group
Reason: Failed Dissolution Specifications: High out of specification result observed at stability studies.