The Harvard Drug Group recalls
FDA enforcement reports naming The Harvard Drug Group as the recalling firm.
- Recall reports
- 55
- Class I (serious)
- 1
- Most recent report
- Jul 1, 2026
- Jul 1, 2026Carton Label: MAJOR, Methylergonovine Maleate Tablets, USP, 0Drug · The Harvard Drug Group LLCSubpotent DrugClass II
- Apr 29, 2026Omega-3-Acid, Ethyl Esters, Capsules, USP, 1 gram, 50 capsules (5 x 10 unit dose bliste…Drug · The Harvard Drug Group LLCFailed Capsule Specifications: Out of specification results obtained during routine stability testing for Loss on Drying of Capsule Shells.Class II
- Apr 22, 2026Memantine Hydrochloride Extended-Release, Capsules, 7 mg, 100 Capsules (10 x 10 blister…Drug · The Harvard Drug Group LLCFailed Dissolution SpecificationsClass II
- Mar 11, 2026Midodrine Hydrochloride Tablets, USP, 5 mg, 50 Tablets (5 x 10 blister packs), Rx only,…Drug · The Harvard Drug Group LLCDefective container; inadequately sealed blister packaging.Class II
- Oct 29, 2025Gabapentin Capsules, USP, 100 mg, 100 Capsules (10 x 10 blister packs), Rx only, Packag…Drug · The Harvard Drug Group LLCFailed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .Class II
- Oct 29, 2025Gabapentin Capsules, USP, 100 mg, 10 Capsules (10 x 1 blister pack), Rx only, Packaged…Drug · The Harvard Drug Group LLCFailed Impurities/Degradation Specifications: an out of specification result obtained during routine stability testing for Highest Unknown Impurity .Class II
- Jul 9, 2025Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons, Rx only,…Drug · The Harvard Drug Group LLCDefective container; blister packaging inadequately sealed.Class II
- Jul 9, 2025Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packaged and Dis…Drug · The Harvard Drug Group LLCDefective container; blister packaging inadequately sealed.Class II
- Jul 5, 2023Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx only, Manufac…Drug · The Harvard Drug GroupPackaging defect: blister packaging inadequately sealed.Class II
- May 17, 2023Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blis…Drug · The Harvard Drug GroupProduct mixup: one foreign tablet found in product.Class III
- Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manu…
- hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx o…
- PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister pa…
- Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Majo…
- Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed…
- Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx only, Manufac…
- NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit do…
- Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufacture…
- Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) un…
- Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 09…
- Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose ca…
- Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton,…
- Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit dose carton,…
- Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit dose carton,…
- Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit dose carton,…
- Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dos…
- Alprazolam Tablets, USP, 0
- Rugby Liquid Vitamin C Supplement, 4 oz
- Major Tri-Vita Drops, 1 2/3 oz (50 mL)
- Rugby D 3 Vitamin Liquid, 400 IUI/1 mL, 1 and 2/3 oz
- Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL)
- Rugby Calcionate Syrup, One Pint (473 mL)
- Rugby Fer-iron Liquid, 1 and 2/3 oz
- Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL)
- Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL)
- Major CertaVite Liquid, 8 oz
- Major Ferrous Drops, 1 2/3 oz (50 mL)
- Major Poly-Vita Drops, 1 2/3 oz (50 mL)
- Major Poly-Vita Drops with Iron, 1 2/3 oz (50 mL)
- Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (50 mL)
- Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL)
- Major D-Vita Drops, 1 2/3 oz (50 mL)
- Rugby Ferrous Sulfate Liquid One Pint, (473 mL)
- Rugby Cerovite Liquid, 8 oz
- Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8
- Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl
- Major Senna Syrup Natural Vegetable Laxative, Sennoside 8
- Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One Pint (473…
- Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (47…
- Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr
- Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by Apotex Inc
- Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr
- Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) b…
- OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by…
- Thera Tablets with Beta Carotene Dietary Supplement
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