Browse Drug Recalls
58 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 58 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 58 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 potential B. cepacia conta... | Class II | The Harvard Drug Group |
| 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 potential B. cepacia conta... | Class II | The Harvard Drug Group |
| 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 potential B. cepacia conta... | Class II | The Harvard Drug Group |
| Jan 5, 2017 | Fluconazole Tablets, USP, 100 mg, 100-count Unit Dose carton, Rx only, Manufa... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| Jan 5, 2017 | Fluconazole Tablets, USP, 200 mg, 100-count Unit Dose carton, Rx only, Manufa... | Failed Dissolution Specifications | Class II | The Harvard Drug Group |
| 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 | The Harvard Drug Group |
| 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 Burkholderia cepacia | Class I | The Harvard Drug Group |
| Jun 10, 2015 | OXYCODONE HCl C-II Tablets, 5 mg USP, 100-count blister cards, Rx only, Manuf... | Superpotent Drug: Confirmed customer complaint of a single unit dose blister cavity containing 2 ... | Class II | The Harvard Drug Group, LLC |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.