Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 5, 2026 | Mirabegron Extended-Release Tablets, 25 mg, 30-count bottle, Rx only, Manufac... | CGMP: Due to Out of Specification (OOS) result for N-Nitroso Mirabegron impurity. | Class II | Zydus Pharmaceuticals (USA) Inc |
| Jul 23, 2026 | Dicyclomine Hydrochloride Capsules, USP, 10mg, 1,000 bottles, Rx only, Distri... | shortfill; reports of empty capsules. | Class II | Aurobindo Pharma USA Inc |
| Jul 23, 2026 | Azelaic Acid Gel, 15%, 50 gram tubes, For Topical Use only, Rx only, Distribu... | CGMP Deviations: Product quality complaints concerning abnormal texture or consistency (described... | Class II | Glenmark Pharmaceuticals Inc., USA |
| Jul 22, 2026 | Dorzolamide HCl and Timolol Maleate Ophthalmic Solution, USP, 2%/0.5%, 10mL -... | Defective Container: Firm received multiple complaints of broken cap spikes and undeliverable drops. | Class II | MICRO LABS USA INC |
| Jul 17, 2026 | Cyclophosphamide for Injection, USP, 1 gram/vial, One Single-Dose Vial, Rx on... | Presence of Particulate Matter; identified as stainless steel | Class I | Sunny Pharmtech Inc. |
| Jul 17, 2026 | Cyclophosphamide for Injection, USP, 2 gram/vial, One Single-Dose Vial, Rx on... | Presence of Particulate Matter; identified as stainless steel | Class I | Sunny Pharmtech Inc. |
| Jul 16, 2026 | Dabigatran Etexilate Capsules, 150 mg, 60-count (6x10) blister pack further p... | Failed impurity/degradation specification: an OOS result observed in Related substance test analy... | Class III | Ascend Laboratories, LLC |
| Jul 16, 2026 | Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient sp... | Incorrect Product Formulation | Class III | Central Admixture Pharmacy Services Inc |
| Jul 16, 2026 | Dabigatran Etexilate Capsules, 75 mg, 30-count (3x10) blister pack further pa... | Failed impurity/degradation specification: an OOS result observed in Related substance test analy... | Class III | Ascend Laboratories, LLC |
| Jul 16, 2026 | Dabigatran Etexilate Capsules, 75 mg, 60-count (6x10)blister pack further pac... | Failed impurity/degradation specification: an OOS result observed in Related substance test analy... | Class III | Ascend Laboratories, LLC |
| Jul 16, 2026 | Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill... | Presence of Particulate Matter: Hair was found in product | Class II | Fresenius Kabi USA, LLC |
| Jul 16, 2026 | Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL)... | Presence of Particulate Matter: Hair was found in products | Class II | Fresenius Kabi USA, LLC |
| Jul 16, 2026 | Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single D... | Presence of Particulate Matter: Hair was found in products | Class II | Fresenius Kabi USA, LLC |
| Jul 16, 2026 | Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL)... | Presence of Particulate Matter: Hair was found in products | Class II | Fresenius Kabi USA, LLC |
| 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 15, 2026 | Lidolog Kit, Kit Contains: Lidocaine HCl Injection, USP, 2% (2mL) vial, 1 Dos... | Labeling: Not Elsewhere Classified: The label wrap covers the barcode, making it hard to scan | Class III | Asclemed USA Inc. |
| 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 30, 2026 | Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manuf... | Failed Impurities/Degradation Specifications: OOS result was observed during the related substanc... | Class III | Ascend Laboratories, LLC |
| Jun 30, 2026 | Dabigatran etexilate Capsules, 150 mg, 20-count carton (2x10), Rx only, Manuf... | Failed Impurities/Degradation Specifications: OOS result was observed during the related substanc... | Class III | Ascend Laboratories, LLC |
| 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 |
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.