Browse Drug Recalls
11 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 11 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 11 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 25, 2026 | Foster & Thrive, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), NDC 70677-1154-0... | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Class II | Bell Pharmaceuticals, Inc |
| Jun 25, 2026 | GOOD NEIGHBOR PHARMACY, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit - ... | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Class II | Bell Pharmaceuticals, Inc |
| Jun 25, 2026 | AUDIOLOGIST'S CHOICE, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL) a) Kit - Was... | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Class II | Bell Pharmaceuticals, Inc |
| Jun 25, 2026 | TopCare Health, CARBAMIDE PEROXIDE 6.5%, 0.5 FL OZ (15 mL) a) Kit - WASHER BU... | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Class II | Bell Pharmaceuticals, Inc |
| Jun 25, 2026 | CVS Health, Carbamide Peroxide, 6.5%, 0.5 FL Oz (15 mL), a) Bottle (NDC 51316... | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Class II | Bell Pharmaceuticals, Inc |
| Jun 25, 2026 | meijer, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Washer Bulb included, NDC... | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Class II | Bell Pharmaceuticals, Inc |
| Jun 25, 2026 | CAREone, Carbamide Peroxide 6.5%, 0.5 FL OZ (15 mL), Bottle, NDC 72476-838-34... | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Class II | Bell Pharmaceuticals, Inc |
| Jun 25, 2026 | FAMILY Wellness, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), Kit - Washer Bul... | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Class II | Bell Pharmaceuticals, Inc |
| Jun 25, 2026 | LEADER, Carbamide Peroxide 6.5%, 0.5 Fl Oz (15 mL), a) Kit -1 RUBBER BULB SYR... | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Class II | Bell Pharmaceuticals, Inc |
| Jun 25, 2026 | Clinere, Carbamide Peroxide, a) 2 bottles of Clinere Carbamide Peroxide (2 x ... | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Class II | Bell Pharmaceuticals, Inc |
| Jun 25, 2026 | QC Quality Choice, Carbamide Peroxide, 6.5%, 0.5 FL. OZ. (15 mL) a) Washer Bu... | SubPotent Drug: low pH and significantly reduced assay (~0.6% vs expected ~6 7%). | Class II | Bell Pharmaceuticals, Inc |
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.