Drug Safety Recalls
Search 17,830 FDA drug recalls and enforcement actions. Check if medications you use have been recalled for safety reasons.
Search Recalls
Find FDA drug recalls by medication name, reason, or manufacturer. Covers all enforcement actions since 2006.
Browse by Year
View drug recalls by year to see trends in pharmaceutical safety enforcement.
Latest Drug Recalls
Most recently initiated FDA drug safety recalls and enforcement actions.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 9, 2026 | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... | Lack of Assurance of Sterility: Affected product may exhibit an open or incomplete seal on the pa... | Class II | CareFusion 213, LLC |
| Jul 6, 2026 | CLEVIPREX (clevidipine injectable emulsion) 50 mg/100 mL (0.5 mg/mL), 10 Sing... | Lack of Assurance of Sterility | Class II | Chiesi USA, Inc. |
| Jun 29, 2026 | Cinacalcet Hydrochloride Tablets, 60 mg, 30-count bottle, Rx Only, Manufactur... | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). | Class II | Cipla USA, Inc. |
| Jun 29, 2026 | Cinacalcet Hydrochloride Tablets, 90 mg, 30-count bottle, Rx Only, Manufactur... | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). | Class II | Cipla USA, Inc. |
| Jun 29, 2026 | Cinacalcet Hydrochloride Tablets, 30 mg, 30-count bottle, Rx Only, Manufactur... | cGMP Deviations: presence of N-nitroso-cinacalcet, above the acceptable daily intake (ADI). | Class II | Cipla USA, Inc. |
| Jun 26, 2026 | Dextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphet... | Labeling: Label Mix-up: Capsules contain only immediate-release (IR) pellets while labeled as ER ... | Class II | Lannett Company Inc. |
| 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 |
Recalls by Year
FDA drug recalls initiated per year.
Top Recalling Firms
Companies with the most FDA drug recall actions.
| # | Firm | Recalls |
|---|---|---|
| 1 | Aidapak Services, LLC | 538 |
| 2 | Attix Pharmaceuticals | 470 |
| 3 | King Bio Inc. | 465 |
| 4 | The Compounding Pharmacy of America | 383 |
| 5 | Main Street Family Pharmacy, LLC | 299 |
| 6 | Pharmedium Services, LLC | 282 |
| 7 | Central Admixture Pharmacy Services, Inc. | 275 |
| 8 | Cardinal Health Inc. | 213 |
| 9 | Franck's Lab Inc., d.b.a. Franck's Compounding Lab | 198 |
| 10 | Teva Pharmaceuticals USA | 196 |
| 11 | Akorn, Inc. | 176 |
| 12 | Dr. Reddy's Laboratories, Inc. | 163 |
| 13 | Mckesson Medical-Surgical Inc. Corporate Office | 157 |
| 14 | First Royal Care Co. LLC, dba Red Mountain Compounding Pharmacy | 140 |
| 15 | Glenmark Pharmaceuticals Inc., USA | 140 |
How It Works
Search Drug Recalls
Enter a medication name, active ingredient, or manufacturer. Our database covers every FDA drug enforcement action from 2006 to 2026.
Review the Details
See the full recall information including classification level, reason for recall, recalling firm, and whether the medication poses serious health risks.
Take Action
If you have a recalled medication, contact your healthcare provider for alternatives. Check the recall details for instructions on returning or disposing of the medication.
Frequently Asked Questions
An FDA drug recall is an action taken to remove a medication from the market because it may be defective, contaminated, improperly manufactured, or mislabeled. Recalls can be initiated voluntarily by the manufacturer or requested by the FDA. Common reasons include cGMP violations, impurity contamination (such as NDMA or other nitrosamines), potency issues, failed sterility testing, and labeling errors.
The FDA classifies drug recalls into three levels. Class I is the most serious, the product may cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible adverse health effects. Class III is the least serious, the product is unlikely to cause adverse health effects.
Do not stop taking critical medications abruptly without consulting your doctor. Contact your healthcare provider for guidance on alternatives. Return recalled medication to the pharmacy for a refund. Report adverse reactions to the FDA through their MedWatch program.
All drug recall data comes from the U.S. FDA through the openFDA enforcement database. We maintain 17,830 drug safety records from 2006 to 2026.