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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

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

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.

DateProductReasonClassFirm
Nov 9, 2023 PHENYLephrine HCl 1000 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentr... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 LET Gel (Lidocaine HCL/Epinephrine Bitartrate/Tetracaine HCL 4%/0.18%/0.5% To... Product Mix-up: Incorrect Product Formulation Class III Right Value Drug Stores, LLC dba Carie Boyd's P...
Nov 9, 2023 HYDROmorphone HCl 30 mg/30mL in 0.9% Sodium Chloride Injection, (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 SUCcinylcholine Chloride 200 mg/10mL Injection (Concentration = 20mg/mL), 10 ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.075% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 2,500 mcg/50 mL Injection (Concentration = 50 mcg/mL), INTRAVENOUS U... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 200 mcg/100 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 100 m... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 500 mcg/5 mL in 0.9% Sodium Chloride Injection, (Concentrat... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 Oxygen, Compressed USP, UN 1072, packaged in cylinders labeled as Size: a) C;... cGMP Deviations Class II Family Medical Supply Inc
Nov 9, 2023 PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 500 mcg/100 mL, Bupivacaine HCl 0.04% in 0.9% Sodium Chloride 100 mL... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 Sodium Citrate 4% 3 mL, Anticoagulation Solution Injection (Concentration = 4... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentratio... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 Midazolam HCl 100 mg/100 mL in 0.9% Sodium Chloride Injection, (Concentration... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 25 mg/25 mL in 0.9% Sodium Chloride Injection, (Concentrati... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentr... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 1... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 20 mg/100mL in 0.9% Sodium Chloride Injection, 100 mL Grey ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 PHENYLephrine HCl 800 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentrati... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 9, 2023 fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = ... Lack of Assurance of Sterility Class II SCA Pharmaceuticals, LLC
Nov 8, 2023 Dr. Ergin's SugarMD, ADVANCED GLUCOSE SUPPORT Capsules, Dietary Supplement, h... MARKETED WITHOUT AN APPROVED NDA/ANDA: Product found to be tainted with metformin and glyburide Class I SUGARMDS LLC
Nov 7, 2023 Naproxen Tablets, USP 250mg, 100-count bottle, Rx Only, Manufactured by: Glen... Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen Class II Glenmark Pharmaceuticals Inc., USA
Nov 7, 2023 Indomethacin 25mg Capsules, USP, 100-count bottle, Rx Only, Manufactured by: ... Labeling: Label Mix-Up-Indomethacin bottles may be labeled as Naproxen Class II Glenmark Pharmaceuticals Inc., USA
Nov 6, 2023 VITRAKVI (larotractenib) oral solution, 20mg/mL, 100 mL bottle, Rx only, Manu... Microbial Contamination of Non-Sterile Products: microbial contamination identified as Penicilliu... Class I Bayer Healthcare Pharmaceuticals Inc.
Nov 6, 2023 Hydrocortisone 1% and Acetic Acid 2% Otic Solution USP, 10ml dropper bottle, ... Failed Impurities/Degradation Specifications:Out-of-Specification result for Hydrocortisone relat... Class III Taro Pharmaceuticals Inc.
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 10 mg a) 30-count bottle, ND... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 30 mg, a)30-count bottle, NDC#... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 20 mg, a) 100-count bottle, ND... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Nov 1, 2023 Trospium Chloride Extended-Release Capsules, 60 mg, 30 Capsules per bottle, R... Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules Class II Padagis US LLC
Nov 1, 2023 Paroxetine Hydrochloride Tablets USP, RX only, 40 mg, 1000-count bottle, NDC#... Failed Impurities/Degradation Specifications-Out of specification (OOS) results for the excipient... Class II Apotex Corp.
Oct 31, 2023 Lubricating Tears Eye Drops (Dextran/Hypromellose), 0.1%/0.3%, packaged in 0.... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I The Harvard Drug Group LLC dba Major Pharmaceut...
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 0.5 F... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Propylene Glycol, 0.6%); 0.33 FL OZ (10 mL)... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Te... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 Polyvinyl Alcohol 1.4% Lubricating Eye Drops, packaged in 0.5 FL OZ (15mL) bo... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I The Harvard Drug Group LLC dba Major Pharmaceut...
Oct 31, 2023 LEADER brand Dry Eye Relief (Polyethylene Glycol 400, 0.4% Propylene Glycol, ... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Lubricant Eye Drops (Carboxymethylcellulose Sodium, 0.5%); 2 bot... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health Inc.
Oct 31, 2023 LEADER brand Dry Eye Relief (Carboxymethylcellulose Sodium, 1%); 0.5 FL OZ (1... Non-Sterility: FDA found insanitary conditions and positive bacterial test results from environme... Class I Cardinal Health 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.