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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

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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
Sep 21, 2023 fentaNYL in 0.9% sodium chloride, 2,500 mcg/250 mL, (10 mcg/mL), 250 mL bag, ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL in 0.9% sodium chloride, 5,000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL in 0.9% sodium chloride, 500 mcg/50 mL, (10 mcg/mL), 50 mL Syringe, ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admix... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total V... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 PHENYLephrine in 0.9 sodium chloride, 800 mcg/10 mL, (80 mcg/mL), 10 mL Syrin... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syring... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL syringe, Rx ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total V... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe,... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 lidocaine 2%, 100 mg/5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 793... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL in 0.9% sodium chloride, 1,000 mcg/100 mL, (10 mcg/mL), 100 mL bag, ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 rocuronium, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx only, Central Admixture ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central ... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 21, 2023 ePHEDrine in 0.9% sodium chloride, 50 mg/5 mL, (10 mg/mL), 5 mL Syringe, Rx o... Lack of assurance of sterility: Class II Central Admixture Pharmacy Services Inc
Sep 5, 2023 Pantoprazole Sodium for Injection 40mg per vial, Single dose vials NDC 71839-... Lack of Assurance of Sterility: Powder discoloration due to small crack in some vials. Class II BE PHARMACEUTICALS AG
Sep 1, 2023 TRP Natural Eyes, Stye Relief, Sterile Eye Ointment, Homeopathic 0.14 oz (4 g... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Blur Relief, Sterile Eye Drops, Homeopathic 0.5 FL OZ (15 m... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Pink Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ ... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Pink Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL ... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Floaters Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ ... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Eye Lid Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL O... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Allergy Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL O... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Dryness Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ (... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Twitching Relief, Sterile Eye Ointment, Homeopathic 0.33 FL... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Dryness Relief PF, Sterile Eye Drops, Homeopathic 0.33 FL O... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 MAJOR LubriFresh P.M. Nighttime Ointment, Lubricant Eye Ointment, Sterile, 0.... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Red Eye Relief, Sterile Eye drops, Homeopathic 0.33 FL OZ (... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Aging Eye Relief, Sterile Eye Drops, Homeopathic 0.33 FL OZ... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Eye Lid Relief, Sterile Eye ointment, Homeopathic 0.14 oz (... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 octiq Lubricating Eye Drops, Dextran 70.01%, Hypromellose 0.3%, 0.5 FL OZ Eac... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Allergy Eyes Relief, Sterile Eye Drops, Homeopathic 0.33 FL... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Sep 1, 2023 TRP Natural Eyes, Red Eye Relief PF, Sterile Eye drops, Homeopathic 0.33 FL O... Lack of Assurance of Sterility Class II AMMAN PHARMACEUTICAL INDUSTRIES
Aug 30, 2023 Sucralfate Oral Suspension 1g per 10mL, FOR ORAL ADMINISTRATION ONLY (414 mL ... Superpotent/Subpotent single ingredient Drug: Out of Specification Assay results Class II VistaPharm LLC
Aug 26, 2023 Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr.... CGMP Deviations Class II Dr. Berne's Whole Health Products
Aug 26, 2023 Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr.... CGMP Deviations Class II Dr. Berne's Whole Health Products
Aug 26, 2023 Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distri... CGMP Deviations Class II Dr. Berne's Whole Health Products
Aug 26, 2023 Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr... CGMP Deviations Class II Dr. Berne's Whole Health Products
Aug 25, 2023 Digoxin Tablets, USP 0.25mg, 100-count bottles, Rx Only, Manufactured for/Di... Labeling: Label Mix-Up- Bottles labeled as Digoxin Tablets, USP 0.125 mg contain Digoxin Tablets,... Class II Marlex Pharmaceuticals, Inc.
Aug 25, 2023 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Stability data does not support expiry: Shelf-life of the impacted lots of BD ChloraPrep" Clear 1... Class II CareFusion 213, LLC
Aug 24, 2023 Doxil (doxorubicin hydrochloride liposome injection) 50 mg in 25 mL (2 mg/mL)... CGMP Deviations: Product was exposed to temperatures exceeding the labeled storage conditions dur... Class II Baxter Healthcare Corporation
Aug 22, 2023 Florbetaben F-18 (Neuraceq¿) Injection Solution 1.4 to 135 mCi/mL, 50 mL in 1... Lack of Assurance of Sterility: out-of-specification test results observed for Filter Integrity T... Class II Sofie Co dba Sofie
Aug 18, 2023 Humanrace Suncare, Ozone Face Protection Daily Moisturizer, Broad Spectrum Su... Subpotent Drug: Product does not contain SPF that is declared on the label. Class II HUMANRACE
Aug 18, 2023 Humanrace Suncare, Ozone Body Protection Cream, Broad Spectrum Sunscreen SPF ... Subpotent Drug: Product does not contain SPF that is declared on the label. Class II HUMANRACE
Aug 17, 2023 CARDIOPLEGIA SOLUTION, HIGH K, Induction 4:1, Plasmalyte/Tromethamine, High P... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 EPINEPHrine added to dextrose 5%, 4mg/250ml (16 mcg/mL), IV Bag, Rx Only, Cen... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, Inc.
Aug 17, 2023 PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, 10 mL Syri... Lack of Assurance of Sterility:Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services, 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.