Recall archive
44 recalls · page 1 of 2
Reported Jul 1, 2026
Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0.2 mg, 20 TABLETS (2 x 10), Rx only, Packaged and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC
Matched: Brand · Reason for recall — Subpotent Drug
FDA (openFDA drug enforcement)
Reported Apr 29, 2026
Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose blister cards) per carton, Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC
Matched: Brand — Failed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.
FDA (openFDA drug enforcement)
Reported Apr 22, 2026
Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC
Matched: Brand — Failed Dissolution Specifications
FDA (openFDA drug enforcement)
Reported Mar 11, 2026
Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only, Packaged and Distributed by:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC
Matched: Brand — Defective container; inadequately sealed blister packaging.
FDA (openFDA drug enforcement)
Reported Oct 29, 2025
Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packaged and Distributed by: Major…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC
Matched: Brand — Failed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Oct 15, 2025
Major ChlorproMAZINE Hydrochloride Tablets, USP, 25 mg, 50 Tablets (5x10) blister package, Rx Only, Packaged and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand — CGMP Deviations: Presence of N-Nitroso Desmethyl Chlorpromazine above the recommended intake limit
4 more products in this recall
FDA (openFDA drug enforcement)
Reported Sep 17, 2025
Sulfamethoxazole and Trimethoprim, USP, 800 mg/160 mg, Double Strength, 100 Tablets unit dose blister packs (10x10) per…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand — Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC)…
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Aug 27, 2025
Carvedilol Tablets USP, 12.5 mg, 100- Tablets, (10x10) cartons, Rx Only, Packaged and distributed by Major…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand — CGMP Deviations: Results for N-Nitroso Carvedilol Impurity-1 (NNCI) impurity observed to be above the FDA-recommended limit of NMT 4.0 ppm
FDA (openFDA drug enforcement)
Reported Jul 9, 2025
Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only, Packaged and Distributed by:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC
Matched: Brand — Defective container; blister packaging inadequately sealed.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Apr 23, 2025
ChlorproMAZINE Hydrochloride Tablets, USP, 10 mg, packaged in cartons of 100 TABLETS (10x10), Rx only, Packaged and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand — CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit
FDA (openFDA drug enforcement)
Reported Apr 9, 2025
Tolterodine Tartrate Extended-Release Capsules, 2 mg, 30 Capsules (3 x 10) Unit Dose carton, Rx only, Packaged and…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand — Failed Dissolution Specifications: Out of specification results obtained during routine stability testing for dissolution.
FDA (openFDA drug enforcement)
Reported Feb 26, 2025
Lorazepam Tablets, USP, 0.5mg, Unit Dose, 100 tablets per carton (10 x 10 blister packs), Rx only, The drug product…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand · Product · Product details · Reason for recall — Failed impurities/degradation specifications and Sub-potent Drug: Out-of-specification results were obtained during routine stability testing for…
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Feb 12, 2025
Potassium Chloride Extended-Release Tablets, USP, 10 mEq (750 mg), 100 Tablets per carton (10 x 10 unit dose blisters),…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand — Failed Dissolution Specifications.
FDA (openFDA drug enforcement)
Reported Feb 5, 2025
Duloxetine Delayed-Release Capsules USP, 20 mg, packaged in a) 30 Unit Doses (3x10 blister packs) NDC 0904-7043-04 and…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand · Reason for recall — CGMP Deviations: presence of Nitrosamine Drug Substances Related Impurity (NDSRI), N-Nitroso-Duloxetine above the FDA recommended acceptable intake…
FDA (openFDA drug enforcement)
Reported Nov 27, 2024
Guaifenesin Dextromethorphan Syrup, 200 mg/20mg per 10 mL, Major Pharmaceuticals 8401 Bearing Drive, Suite 100,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand — Failed Impurity/Degradation Specifications
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Nov 20, 2024
Hydralazine HCl Tablets, USP, 25mg, Rx only, 100 tablets per carton, Distributed by: Avet Pharmaceuticals Inc., East…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand — Failed Impurities/Degradation Specifications; during routine stability testing for impurities.
FDA (openFDA drug enforcement)
Reported Jul 10, 2024
Venlafaxine Hydrochloride, extended-release capsules, USP, 37.5mg, 10 x 10 blister card in one carton, Rx only, Mfg by:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand — Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.
FDA (openFDA drug enforcement)
Reported Feb 21, 2024
HydrALAZINE Hydrochloride Tablets, USP 10mg, packaged in 100-count (10x10 blister cards), Lot T04680, Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand — an out of specification result obtained during routine stability testing for Impurities. There is a remote possibility that use of this product could…
FDA (openFDA drug enforcement)
Reported Dec 27, 2023
Phenytoin Oral Suspension, USP, 100 mg/4 mL, packaged in packaged in 4 mL unit dose cups (NDC 0904-7079-24), 50 per…
High riskUsing this product could cause serious injury, illness or death — stop using it now.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand — Failed Content Uniformity Specifications
FDA (openFDA drug enforcement)
Reported Nov 29, 2023
Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bottles, Dist. by: RUGBY LABORATORIES,…
High riskUsing this product could cause serious injury, illness or death — stop using it now.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand — Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environmental sampling at the manufacturing facility.
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Nov 1, 2023
The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories recalls Rugby OTC Ophthalmic Sterile Drops due to Insanitary manufacturing…
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.The Harvard Drug Group, LLC dba Major Pharmaceutical and Rugby Laboratories
Matched: Brand · Product · Product details — Insanitary manufacturing conditions
FDA (recalls & safety alerts)
Reported Jul 5, 2023
Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufactured by: Sun Pharmaceutical…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Brand — Packaging defect: blister packaging inadequately sealed.
FDA (openFDA drug enforcement)
Reported Jun 28, 2023
ZIPRASIDONE HYDROCHLORIDE CAPSULES 20 mg, Unit Dose Carton 40 Capsules, Rx only, Mfd. By: Dr. Reddy's Laboratories…
High riskUsing this product could cause serious injury, illness or death — stop using it now.The Harvard Drug Group LLC dba Major Pharmaceuticals and Rugby Laboratories
Matched: Brand — Labeling: Label Mix-up: Unit Dose cartons labeled as Ziprasidone Hydrochloride Capsules, 20 mg were found to contain blister packages labeled as and…
FDA (openFDA drug enforcement)
Reported Jun 14, 2023
The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories recalls Major Pharmaceuticals Dronabinol Capsules 2.5mg and Ziprasidone…
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.The Harvard Drug Group, LLC d/b/a Major Pharmaceutical and Rugby Laboratories
Matched: Brand · Product · Product details — Packaging may contain incorrect product due to labeling mix-up
FDA (recalls & safety alerts)
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