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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

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
Jul 14, 2017 morphine sulfate 1 mg per mL in 0.9% Sodium Chloride, (Total morphine Dose 10... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... Class II SCA Pharmaceuticals
Jul 14, 2017 Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 25 mg/5 mL (5 mg/mL) Single-D... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 ePHEDrine Sulfate 5 mg/mL in NS 5 mL Fill in 12 mL Syringe (25 mg), Rx only, ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Sodium Bicarbonate 8.4% Injection Solution 50 mL, 50 mEq (1mEq/mL) Single-Dos... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 fentaNYL as citrate 5 mcg/mL in 0.9% Sodium Chloride 1 mL in Single Dose syri... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 PHENYLephrine 10 mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmace... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Succinylcholine Chloride Injection Solution 10 mL, 200 mg/10 mL (20 mg/mL) Si... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 BUPIVacaine HCl 0.2% IN 0.9% Sodium Chloride 250 mL Bag Preservative Free (To... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 NORepinephrine 4 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx only, SCA P... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Ephedrine Sulfate Injection Solution 1 mL, 50 mg/1 mL (50 mg/mL) Single-Dose... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 BUPIVacaine HCl 0.1% PF (From 0.75%) in 0.9% Sodium Chloride, 250 mL Bag, Pre... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Succinylcholine Chloride Injection Solution 5 mL, 100 mg/5 mL (20 mg/mL) Sing... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Norepinephrine Bitartrate 16 mg Added to 0.9% Sodium Chloride 250 mL (64 mcg ... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Potassium Chloride 20 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Glycopyrrolate Injection Solution, 2 mL 0.4 mg/2 mL (0.2 mg/mL) Single-Dose S... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Potassium Chloride 40 meq Added to Sodium Chloride 0.9% 250 mL, Rx only, SCA ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Adenosine in 0.9% Sodium Chloride 30mL, 90 mg/30 mL (3 mg/mL) Single-Dose Syr... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Norepinephrine Bitartrate 8 mg Added to 0.9% Sodium Chloride 250 mL (32 mcg p... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 fentaNYL 10 mcg/mL PF in Sodium Chloride 250 mL (Total Dose=2500 mcg), Rx onl... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 NORepinephrine Bitartrate 8 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA P... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 NORepinephrine Bitartrate 16 mg in 0.9% Sodium Chloride 250 mL from Stock, Rx... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 PHENYLephrine HCl 25 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmace... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 PHENYLephrine 100 mg in 0.9% Sodium Chloride 250 mL Bag, Rx only, SCA Pharmac... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL 3 mcg/mL + BUPIvacaine 0.1% in 0.9% Sodium Chloride 250 mL, Rx only,... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 EPINEPHrine HCl 4 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceut... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride, (Final Concentration = 0.1 m... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... Class II SCA Pharmaceuticals
Jul 14, 2017 Diltiazem HCl 125 mg in 5% Dextrose 125 mL Single-Dose- Bag, Rx Only, Cantre... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Norepinephrine Bitartrate 4 mg Added to 0.9% Sodium Chloride 250 mL (16 mcg ... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Ephedrine Sulfate in 0.9% Sodium Chloride 10 mL, 50 mg/10 mL (5 mg/mL) Single... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 12, 2017 Testosterone Cypionate + Progesterone, 200 mg/ 2.5 mg/mL ,10 mL amber glass ... CGMP Deviations Class II Fusion IV Pharmaceuticals, Inc. dba Axia Pharma...
Jul 6, 2017 0.9% Sodium Chloride Injection USP, 250 mL VIAFLEX Container bag, Rx only, Ba... Lack of Assurance of Sterility: Customer complaints for leaking bags. Class II Baxter Healthcare Corporation
Jul 6, 2017 5% Dextrose Injection, USP, 100 mL VIAFLEX Plastic Container, Rx only, Baxte... Lack of Assurance of Sterility: Bags have the potential to leak. Class II Baxter Healthcare Corporation
Jul 6, 2017 0.9% Sodium Chloride Injection, USP, 100 mL VIAFLEX Container, Rx Only, Baxt... Lack of Assurance of Sterility: Bags have the potential to leak. Class II Baxter Healthcare Corporation
Jul 5, 2017 Carbamazepine Oral Suspension, USP. 100 mg/5 mL, 5 mL Unit Dose Cups, Rx Only... Labeling Error: Label mix-up. Products' unit dose cups are correctly labeled, but the product ca... Class II Precision Dose Inc.
Jun 28, 2017 parodontax WHITENING (Stannous fluoride) Daily Fluoride Anticavity and Antigi... Presence of Foreign Substance: possibility of the presence of metal in the product. Class II GSK Consumer Healthcare
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7.5 mMol in 100 mL in ... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 30 mMol in a) 250 mL i... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 5% Dextrose Injection, 30 mMol 500 mL in 500 mL Intrav... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection 20 mMol in 100 mL in 15... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Lactulose Solution, USP, 20 g/30 mL, dose cups delivers 30 mL packaged 50-uni... Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. Class II VistaPharm, Inc.
Jun 26, 2017 Succinylcholine Chloride Injection (Preserved) 20 mg per mL, 200 mg per 10 mL... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 7 mMol in 100 mL in 15... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 9 mMol in 100 mL in 15... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 10 mMol in a) 100 mL i... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Lactulose Solution, USP, 10 g/15 mL, dose cups delivers 15 mL packaged in 50-... Microbial contamination of non-sterile product: product failed Total Yeast/Mold Count specification. Class II VistaPharm, Inc.
Jun 26, 2017 Potassium PHOSphate in 5% Dextrose Injection, 7.5 mMol in 100 mL in 150 mL In... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection, 40 mMol in 250 mL in 2... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 5% Dextrose Injection, 9 mMol in 50 mL in 50 mL Intrav... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 5% Dextrose Injection, 15 mMol in 250 mL in 250 mL Int... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, Llc
Jun 26, 2017 Potassium PHOSphate in 0.9% Sodium Chloride Injection 15 mMol in a) 100 mL in... Lack of Assurance of Sterility; media fill failure at manufacturer Class II PharMedium Services, 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.