Public Health Trace republishes official recall, outbreak, and surveillance data from CDC, FDA, USDA,
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Policy version 2026-07-21, effective July 21, 2026.
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Based on the official records currently available to Public Health Trace, no recalls naming The Harvard Drug Group are currently shown as ongoing. The 45 records below are historical recall records.
Public Health Trace has 45 recalls naming The Harvard Drug Group as the recalling firm, republished from official FDA and USDA sources.
Recall history - 45 terminated records
Recalls by year
A bar chart of the number of recalls naming this company by year.
FDA RecallTerminatedTerminated: April 30, 2024Historical recordClass II
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 Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Distributed by: Major Pharmaceuticals Livonia, MI 48152 USA, NDC 0904-7179-61
FDA RecallTerminatedTerminated: April 30, 2024Historical recordClass III
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 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA, NDC 0904-6823-61
by The Harvard Drug Group
Reason
Product mixup: one foreign tablet found in product.
FDA RecallTerminatedTerminated: June 8, 2023Historical recordClass II
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 PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61
FDA RecallTerminatedTerminated: July 16, 2023Historical recordClass II
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
FDA RecallTerminatedTerminated: February 19, 2023Historical recordClass II
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
FDA RecallTerminatedTerminated: December 28, 2022Historical recordClass II
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 32839-6408 Distributed by: Major Pharmaceuticals 17177 N Laurel Park Dr., Suite 233 Livonia, MI 48152 USA
by The Harvard Drug Group
Reason
Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
FDA RecallTerminatedTerminated: February 19, 2023Historical recordClass II
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, Livonia, MI 48152 USA, NDC 0904-6512-04
by The Harvard Drug Group
Reason
Failed Dissolution Specifications: Out of specification for dissolution.
FDA RecallTerminatedTerminated: October 2, 2022Historical recordClass II
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; Distributed by: Major Pharmaceuticals, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152.
by 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.
Some FDA recall records on this page come from FDA's Enforcement Report database.
Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
This page lists recalls that name The Harvard Drug Group as the recalling firm in the official source notice. It is
not a safety rating, ranking, or statement that the company acted negligently.
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