The Harvard Drug Group
Complete recall history across all FDA and CPSC categories — 45 total recalls
Recall Summary
The Harvard Drug Group appears in recall records across 2 categories. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Food Recalls (17)
FDA food safety enforcement actions by The Harvard Drug Group
| Date | Product | Reason | Class |
|---|---|---|---|
| Aug 2, 2017 | Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL) | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Rugby D 3 Vitamin Liquid, 400 IUI/1 mL, 1 and 2/3 oz., 50 mL | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Major Tri-Vita Drops, 1 2/3 oz (50 mL) | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Rugby Cerovite Liquid, 8 oz. 236ML | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Rugby Liquid Vitamin C Supplement, 4 oz., 118 mL | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Rugby Ferrous Sulfate Liquid One Pint, (473 mL) | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Major D-Vita Drops, 1 2/3 oz (50 mL) | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL) | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Major Poly-Vita Drops with Iron, 1 2/3 oz (50 mL) | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Rugby Calcionate Syrup, One Pint (473 mL) | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL) | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (5... | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Major Poly-Vita Drops, 1 2/3 oz (50 mL) | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL) | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Major CertaVite Liquid, 8 oz. (236 mL) | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
| Aug 2, 2017 | Major Ferrous Drops, 1 2/3 oz (50 mL) | The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard D... | Class II |
Drug Recalls (28)
FDA drug safety enforcement actions by The Harvard Drug Group
| Date | Product | Reason | Class |
|---|---|---|---|
| Jun 16, 2023 | Tramadol Hydrochloride Tablets, USP 50 mg, Unit Dose 100-Count Tablets Rx onl... | Packaging defect: blister packaging inadequately sealed. | Class II |
| Apr 24, 2023 | Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablet... | Product mixup: one foreign tablet found in product. | Class III |
| Feb 23, 2023 | Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx ... | Packaging defect: observed packaging defect, blister packaging inadequately s... | Class II |
| Feb 28, 2022 | PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 ... | Failed Dissolution Specifications | Class II |
| Feb 24, 2022 | hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister pa... | Failed Impurities/Degradation Specifications: Out of specification result obt... | Class II |
| Aug 6, 2021 | Carbamazepine 200mg Tablets, USP, 200 mg, 100 Count Unit Dose Cartons, Rx onl... | Failed Dissolution Specifications | Class II |
| Aug 3, 2021 | Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distribute... | Failed Impurities/Degradation Specifications | Class II |
| Jul 29, 2021 | Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, D... | Failed Dissolution Specifications | Class II |
| Jul 2, 2021 | NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 cou... | Failed Dissolution Specification: Out of specification for dissolution during... | Class II |
| Nov 18, 2020 | Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, M... | Failed Dissolution Specifications: Out of specification for dissolution. | Class II |
| Jun 12, 2020 | Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (1... | CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity a... | Class II |
| May 22, 2020 | Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose carto... | Failed Dissolution Specification: The dissolution test at the 24 month time p... | Class II |
| Apr 24, 2020 | Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per un... | Failed dissolution specifications: Low stage 3 results obtained for dissoluti... | Class III |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dos... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the ... | Class III |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 200 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the ... | Class III |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 300 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the ... | Class III |
| Feb 27, 2020 | Quetiapine Fumarate Extended-Release Tablets, 150 mg, 100 tablets per unit do... | Labeling; Incorrect or Missing Package Insert: Product was packaged with the ... | Class III |
| Dec 13, 2019 | Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-coun... | Failed Dissolution Specifications: High out of specification result observed ... | Class III |
| Sep 26, 2017 | Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx ... | Failed Impurities/Degradation Specifications: Out-of-specification result for... | Class II |
| Aug 2, 2017 | Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl o... | Microbial contamination of Non-sterile Products; presence of yeast and potent... | Class II |
| Aug 2, 2017 | Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (23... | Microbial contamination of Non-sterile Products; presence of yeast and potent... | Class II |
| Aug 2, 2017 | Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120... | Microbial contamination of Non-sterile Products; presence of yeast and potent... | Class II |
| Aug 2, 2017 | Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, On... | Microbial contamination of Non-sterile Products; presence of yeast and potent... | Class II |
| Aug 2, 2017 | Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One... | Microbial contamination of Non-sterile Products; presence of yeast and potent... | Class II |
| Jan 5, 2017 | Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufa... | Failed Dissolution Specifications | Class II |
| Jan 5, 2017 | Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufa... | Failed Dissolution Specifications | Class II |
| Dec 27, 2016 | Aripiprazole Tablets, 2 mg, 30 count unit dose box, Rx only, Manufactured by ... | Superpotent Drug; out of specification results for assay (manufacturer) | Class III |
| Jul 15, 2016 | Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint ... | Microbial contamination of Non-Sterile Products; positive findings of Burkhol... | Class I |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
Yes. You can search for any company using the firm/manufacturer pages for each category: Food Firms, Drug Firms, Device Firms, or Product Manufacturers. You can also use the search functionality on any browse page to find recalls by company name.
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