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Vehicle Safety

Vehicle Recalls320,000+ NHTSA safety recalls Browse VehiclesEvery make, model and year Complaints2.1M+ consumer safety complaints TSBs4.7M technical service bulletins VIN LookupDecode any vehicle VIN instantly OBD Codes12,000+ diagnostic trouble codes Fuel EconomyEPA MPG data for all vehicles Safety Ratings11,700+ NHTSA crash test ratings Investigations5,300+ NHTSA defect investigations StatisticsRecall trends & safety analysis Compare VehiclesTwo vehicles side by side

Consumer Safety

Product Safety9,700+ CPSC product recalls Food Safety28,600+ FDA food recalls Pet Safety1.3M FDA animal adverse events Drug Safety17,500+ FDA drug recalls Device Safety38,400+ FDA device recalls Workplace Safety102,900+ OSHA injury reports Brand HistoryRecall lookup by company

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Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Dec 6, 2021 Phenylephrine HCl/Tropicamide, Sterile Ophthalmic Solution, 2.5%/1%, 15 mL pe... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Edetate Disodium (EDTA), Sterile Ophthalmic Solution, (PF) 3%, 10mL per dropp... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Mitomycin-C, Sterile Ophthalmic Solution, Preservative Free, 0.16mg/0.8mL (0.... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 CSF-HC Otic Insufflation Capsule, Sulfacetamide Sodium/Ciprofloxacin/Hydrocor... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 MVASI, (bevacizumab-awwb), Sterile Ophthalmic Solution for Injection, 3.25mg/... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Cefuroxime, Sterile Ophthalmic Solution for Injection, Preservative Free, 3mg... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Neostigmine methylsulfate, 5 mg/5mL (1 mg/mL), 5 mL per syringe, Single Use S... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Lidocaine HCl Sterile Buffered Solution for Injection (PF) 1%, 10mL per syrin... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl / Tropicamide / Ciprofloxcin / Ketorolac Sterile Ophthalmic... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Dexamethasone sodium phosphate 0.4%, 120 mL per bottle, Multiple Dose Contain... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Phenol, Topical Solution (PF) Multiple Dose Vial, 89%, 3 mL per vial, Edge Ph... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Profound-PE Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl/Phenyleph... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Gemcitabine, Sterile Intravesical Solution, Preservative Free, 1g/50mL (20 mg... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Dibutyl Squaric Acid, Topical Solution (PF), Multiple Dose Vial, 2%, 10 mL pe... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10% / 10% /... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Epinephrine/Lidocaine HCl Sterile Ophthalmic Solution for Injection, Preserva... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Dexamethasone sodium phosphate, sterile otic solution for injection Preservat... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Vancomycin HCl in 0.9% Sodium Chloride Injection, 1,500 mg/500 mL, USP, Singl... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl, 1mg/10mL (0.1mg/mL), 10 mL per syringe, Single Use Syringe... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 LET Topical Gel, Lidocaine HCL / Epinepherine / Tetracaine HCl, 4%/0.05%/0.5%... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Profound Dental Gel, Lidocaine HCl/Prilocaine HCl/Tetracaine HCl, 10%/10%/4% ... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 ALUM Concentrate (Aluminum Potassium Sulfate Dodecahydrate in Sterile Water (... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Vancomycin HCl in 0.9% Sodium Chloride Injection, USP, 1,750mg/500mL, Single ... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Promethazine HCl Topical Ointment, 2.5% (25 mg/mL), 1.2 mL per syringe, Singl... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Profound-PE Dental Gel, Lidocaine HCl/ Prilocaine HCl/ Tetracaine HCl/ Phenyl... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Vitamin K (Vitamin K ) Oral Solution (PF), 5 mg/mL, 1mL per syringe, single D... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl/Tropicamide/Cyclopentolate HCl/ Ketorolac Sterile Ophthalmi... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Betadine (povidone-iodine), Sterile Ophthalmic Solution, Preservative Free, 5... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syring... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Cantharidin PLUS, Cantharidin/Salicylic Acid Gel-Forming Suspension, 10 mL pe... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Lidocaine HCl / Oxymetazoline HCl Nasal Solution, 4% / 0.05%, 240mL per bottl... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Moxifloxacin, Sterile Ophthalmic Solution for Injection, Preservative Free, 0... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Dibutyl Squaric Acid, Topical Solution (PF) Multiple Dose Vial, 1%, 10 mL per... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Lidocaine HCl/Epinephrine, Sterile Buffered Solution for Injection (PF) 1% / ... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 BLT Topical Cream, Benzocaine/Lidocaine/Tetracaine, 20%/8%/4%, 60gm per jar, ... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Phenylephrine HCl/Lidocaine, Sterile Ophthalmic Solution for Injection, Prese... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Mitomycin-C Sterile Ophthalmic Solution, Preservative Free, 0.32mg/0.8 mL (0.... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Vancomycin HCl, Sterile Ophthalmic Solution for Injection, Preservative Free,... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL), Sterile... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 PHENYLephrine, 0.9% Sodium Chloride Injection, USP, 20 mg/250mL, (0.08 mg/mL)... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injecti... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 LT Topical Cream, Lidocaine/Tetracaine, 23%/7%, 60gm per jar, Multiple Dose C... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg... CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... Class II Medique Products
Dec 6, 2021 Lidocaine HCl/Phenylephrine HCl Nasal Solution, 4%/1%, 240 mL per bottle, Mul... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Vancomycin HCl in 0.9 % Sodium Chloride Injection, USP, 1,250 mg/250 mL, Sing... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Ceftazidime, Sterile Ophthalmic Solution for Injection, Preservative Free (11... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 CSF Otic Insufflation Capsule, Sulfacetamide Sodium/ Ciprofloxacin/ Amphoteri... CGMP Deviations Class II Edge Pharma, LLC
Dec 6, 2021 Methotrexate, USP, Sterile Solution for Injection (PF), 125 mg/5mL (2mg/mL), ... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 6, 2021 Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 ... CGMP Deviations: manufacturer recalled after an FDA inspection noted that these products were not... Class II Medique Products
Dec 6, 2021 Tetracaine HCl Nasal Solution, 4%, 240 mL per bottle, Multiple Dose Container... CGMP Deviations Class II Edge Pharma, LLC

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.