Browse Drug Recalls
9 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 9 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 9 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 15, 2015 | SENSODYNE WITH FLUORIDE REPAIR & PROTECT, a) 0.8 oz.(23 g) tubes, (NDC 0135-0... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 15, 2015 | biotene Gentle Formula FLUORIDE TOOTHPASTE Fresh Mint Original, a) 0.70 oz (1... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 15, 2015 | biotene Gentle Mint Gel, 4.5 oz.(127.6 g) tubes, Manufactured by Oratech, Sou... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 15, 2015 | biotene Gentle Formula FLUORIDE TOOTHPASTE GENTLE MINT , 4.3 oz.(121.9 g) tub... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 15, 2015 | biotene PBF Toothpaste (Plaque-Biofilm Loosening Formula), a) 4.3 oz. (121.9 ... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 15, 2015 | SENSODYNE COMPLETE PROTECTION, 3.4 oz. (96.4 g)tubes, Manufactured by Oratech... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 15, 2015 | SENSODYNE EXTRA FRESH COMPLETE PROTECTION, 3.4 oz.(96.4 g) tubes, Manufacture... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jul 15, 2015 | SENSODYNE EXTRA FRESH REPAIR & PROTECT, 3.4 oz. (96.4 g) tubes, Manufactured ... | Presence of Foreign Substance: Fragments of wood found when the product was extruded onto a tooth... | Class II | GlaxoSmithkline Consmer Healthcare |
| Jun 30, 2015 | Panadol (acetaminophen) Extra Strength, 500 mg, a) 30 count (UPC 1-03-53100-9... | Failed Dissolution Specifications | Class III | GlaxoSmithkline Consmer Healthcare |
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.