Browse Drug Recalls
14,572 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,572 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 14,572 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 16, 2026 | Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5... | Presence of Particulate Matter: Hair was found in products | Class II | Fresenius Kabi USA, LLC |
| Jul 14, 2026 | Glycopyrrolate Oral Solution, 1 mg/5 mL, delivers 5 mL, Rx only, Pkg: Precisi... | Failed Impurities/Degradation Specifications | Class II | Precision Dose Inc. |
| Jul 14, 2026 | Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Ster... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 14, 2026 | Rohto Cooling Eye Drops ALL-IN-ONE (hypromellose 0.2%, tetrahydrozoline HCL 0... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 14, 2026 | Rohto Cooling Eye Drops Optic Glow (naphazoline hydrochloride 0.03%, povidone... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 14, 2026 | Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polyso... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 14, 2026 | Rohto Cooling Eye Drops Dry Aid (povidone 0.68%, propylene glycol 0.3%), Ster... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 14, 2026 | Rohto Cooling Eye Drops Digi Eye (hypromellose 0.35%, tetrahydrozoline HCl 0.... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 14, 2026 | Rohto Cooling Eye Drops Cool Relief (naphazoline hydrochloride 0.012%, polyso... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 14, 2026 | Rohto Cooling Eye Drops Max Strength (naphazoline hydrochloride 0.03%, polyso... | Lack of Assurance of Sterility | Class II | Rohto-Mentholatum (Vietnam) Co., Ltd. |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 100 Tablets (10 x 10 ... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx o... | Presence of Precipitate: medication was crystallizing and particles floating in the bottle | Class II | Rising Pharma Holding, Inc. |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 10 Tablets (10 x 1) uni... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 100 Tablets (10 x 10 ... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.0112 mg), 100 Tablets (10 x 10 ... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 10 Tablets (10 x 1) uni... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.050 mg), 100 Tablets (10 x 10 un... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 100 Tablets (10 x 10 un... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 125 mcg (0.0125 mg), 10 Tablets (10 x 1) u... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 100 Tablets (10 x 10 un... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 100 Tablets (10 x 10 un... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.0150 mg), 10 Tablets (10 x 1) u... | Subpotent Drug | Class II | Major Pharmaceuticals |
| Jul 13, 2026 | Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 10 Tablets (10 x 1) uni... | Subpotent Drug | Class II | Major Pharmaceuticals |
| 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 8, 2026 | Amlodipine and Olmesartan Medoxomil Tablets, 10 mg/20 mg, 30 Tablets per bott... | Failed Dissolution Specifications; Olmesartan Medoxomil content below specifications | Class II | Ascend Laboratories, 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. |
| Jul 2, 2026 | Mycophenolate Mofetil for Injection USP, 500 mg/Vial, Single Dose Vial, 4 via... | Presence of precipitate | Class II | MYLAN PHARMACEUTICALS 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 | Divalproex Sodium Delayed-Release Tablets, USP, 500 mg, 500 Tablets bottles, ... | Presence of Foreign Tablets/Capsules | Class II | Bionpharma 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 |
| 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 |
| Jun 24, 2026 | Methohexital Sodium, 100 mg/10 mL (10 mg/mL), Total Volume: 10 mL, Rx only, C... | Failed Impurities/Degradation Specifications | Class II | QuVa Pharma, Inc. |
| Jun 24, 2026 | Azacitidine for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, Fo... | Lack of Sterility Assurance | Class II | Reliance Life Sciences Private Limited |
| Jun 24, 2026 | Pemetrexed for Injection 100mg/Vial, 1 10 mL Single-Dose Vial per carton, For... | Lack of Sterility Assurance | Class II | Reliance Life Sciences Private Limited |
| Jun 24, 2026 | Bortezomib for Injection 3.5mg/Vial, 10 mL per Single-Dose Vial, For Intraven... | Lack of Sterility Assurance | Class II | Reliance Life Sciences Private Limited |
| Jun 24, 2026 | Pemetrexed for Injection 500mg/Vial, 1 50 mL Single-Dose Vial per carton, For... | Lack of Sterility Assurance | Class II | Reliance Life Sciences Private Limited |
| Jun 23, 2026 | Nystatin Cream USP, (100,000 USP Nystatin Units), NET WT 15 g, Rx only, 15 g ... | Subpotent Drug: Low out of specification assay results performed during long-term stability testing. | Class II | Padagis US LLC |
| Jun 23, 2026 | Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg p... | CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long... | Class II | Lupin 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.