Browse Drug Recalls
10 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 10 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 10 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Feb 20, 2014 | Nicotine polacrilex lozenge, 4 mg, Cherry Flavor, 72 count cartons, 81 count ... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 20, 2014 | Nicotine polacrilex lozenge, 2 mg, Mint Flavor, 81 count cartons and 189 coun... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 20, 2014 | Nicotine polacrilex lozenge, 4 mg, Mint Flavor, 81 Lozenge and 189 Lozenge Vi... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 20, 2014 | Nicorette (nicotine polacrilex) Lozenges Mini, 2 mg, Original Flavor, 20 Loze... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 20, 2014 | Nicotine polacrilex lozenge, 4 mg, Original Flavor, 72 count cartons, 81 coun... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 20, 2014 | Nicotine polacrilex lozenge, 2 mg, Cherry Flavor, 72 count vials, 81 count vi... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 20, 2014 | Nicorette (nicotine polacrilex) Lozenges Mini, 4 mg, Original Flavor, 20 Loze... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 20, 2014 | Nicorette Lozenge, Nicoderm CQ, and Nicorette Gum nicotine polacrilex combin... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 20, 2014 | Nicotine polacrilex lozenge, 2 mg, Original Flavor, 72 count cartons, 81 coun... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
| Feb 20, 2014 | Nicorette Lozenge and NicoDerm CQ, nicotine polacrilex system. 189 2mg Mint F... | Failed Lozenge Specifications; Lozenges are overly thick, overly soft, and sub and superpotent. | Class III | GlaxoSmithKline Consumer Healthcare; dba-GlaxoS... |
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.