Recall archive
44 recalls · page 2 of 2
Reported May 17, 2023
Gabapentin Tablets, USP 600 mg, packaged in Cartons of 100 tablets (10 tablets per blister pack x 10), Rx Only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.The Harvard Drug Group
Matched: Brand — Product mixup: one foreign tablet found in product.
FDA (openFDA drug enforcement)
Reported Mar 8, 2023
Carbidopa and Levodopa Tablets, USP 25 mg/100 mg, 10x10 Unit Dose carton, Rx Only, Manufactured in Czech Republic by:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Brand — Packaging defect: observed packaging defect, blister packaging inadequately sealed.
FDA (openFDA drug enforcement)
Reported Mar 23, 2022
hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister packs), Rx only, Distributed by: MAJOR…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Brand — Failed Impurities/Degradation Specifications: Out of specification result obtained during routine stability testing for Impurities.
FDA (openFDA drug enforcement)
Reported Mar 16, 2022
PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Brand — Failed Dissolution Specifications
FDA (openFDA drug enforcement)
Reported Dec 29, 2021
Fexofenadine Hydrochloride Tablets, 60 mg, 500 Tablets per bottle, Distributed by: Major Pharmaceuticals, 17177 N.…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Brand — Failed Impurities/Degradation Specifications
FDA (openFDA drug enforcement)
Reported Sep 29, 2021
Entacapone Tablets, USP, 200 mg, Rx only, 30 Tablets per unit dose cartons, Distributed by: Major Pharmaceuticals,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Brand — Failed Dissolution Specifications
1 more product in this recall
FDA (openFDA drug enforcement)
Reported Jul 21, 2021
NIFEdipine EXTENDED-RELEASE TABLETS, USP 30 mg Rx only packaged as a) 100 count unit dose carton, NDC 0904-7080-61; b)…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Brand — Failed Dissolution Specification: Out of specification for dissolution during routine stability testing.
FDA (openFDA drug enforcement)
Reported Dec 9, 2020
Aripiprazole Tablets, USP, 15 mg, 30 tablets per unit dose carton, Rx Only, Manufactured by: Apotex, Inc, Toronto,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Brand — Failed Dissolution Specifications: Out of specification for dissolution.
FDA (openFDA drug enforcement)
Reported Jul 8, 2020
Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 100 Tablets (10 x 10) unit dose cartons, Rx only,…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Brand — CGMP Deviation: Potential presence of Nitrosodimethylamine (NDMA) Impurity above the established levels.
FDA (openFDA drug enforcement)
Reported Jun 10, 2020
Doxycycline Hyclate Tablets, USP, 100 mg, packaged in a) 3x10 unit dose cartons (NDC 0904-0430-04) and b) 5 x 10 unit…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Brand — Failed Dissolution Specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out-of-specification result.
FDA (openFDA drug enforcement)
Reported May 20, 2020
Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by:…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.The Harvard Drug Group
Matched: Brand — Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
FDA (openFDA drug enforcement)
Reported Mar 18, 2020
Quetiapine Fumarate Extended-Release Tablets, 50 mg, 100 tablets per unit dose carton, Rx only, Manufactured by: Lupin…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.The Harvard Drug Group
Matched: Brand — Labeling; Incorrect or Missing Package Insert: Product was packaged with the package insert for Quetiapine Fumarate Tablets not Quetiapine Fumarate…
3 more products in this recall
FDA (openFDA drug enforcement)
Reported Feb 26, 2020
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in 100-count Unit Dose Cartons , Rx only,…
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.The Harvard Drug Group
Matched: Brand — Failed Dissolution Specifications: High out of specification result observed at stability studies.
FDA (openFDA drug enforcement)
Reported Oct 25, 2017
Alprazolam Tablets, USP, 0.25 mg, 100-count Unit Dose tablets per carton, Rx Only, Manufactured by: Watson Pharma…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Brand — Failed Impurities/Degradation Specifications: Out-of-specification result for an unknown impurity.
FDA (openFDA drug enforcement)
Reported Sep 20, 2017
Rugby Calcionate Syrup, One Pint (473 mL)
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Brand · Reason for recall — The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary…
16 more products in this recall
FDA (openFDA food enforcement)
Reported Aug 30, 2017
Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, One Pint (473 mL) plastic bottles, Dist. by:…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Brand — Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia contamination
4 more products in this recall
FDA (openFDA drug enforcement)
Reported May 10, 2017
Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufactured by Dr. Reddy's Laboratories…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group
Matched: Brand — Failed Dissolution Specifications
2 more products in this recall
FDA (openFDA drug enforcement)
Reported Oct 19, 2016
Diocto Liquid (docusate sodium) 50 mg/5 mL Stool Softener Laxative, One Pint (473 mL) bottles, Dist by: Rugby…
High riskUsing this product could cause serious injury, illness or death — stop using it now.The Harvard Drug Group
Matched: Brand — Microbial contamination of Non-Sterile Products; positive findings of Burkholderia cepacia
FDA (openFDA drug enforcement)
Reported Jul 8, 2015
OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manufactured by Nesher Pharmaceuticals USA…
Moderate riskThis product could cause temporary or reversible health problems — stop using it.The Harvard Drug Group, LLC
Matched: Brand · Reason for recall — Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 OXYCODONE HCl 5 mg tablets.
FDA (openFDA drug enforcement)
Reported Feb 4, 2015
Thera Tablets with Beta Carotene Dietary Supplement
Low riskThis product is unlikely to cause harm, but it breaks a safety or labelling rule.The Harvard Drug Group, LLC
Matched: Brand — The firm received a complaint that the blister packets were missing labeling information on 12/16/2014, the firm investigated the labeling complaint…
FDA (openFDA food enforcement)
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