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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
Aug 10, 2017 Amiodarone 900 mg in dextrose 5% 500 mL, 500 mL bag, Concentration: 1.8 mg/mL... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Morphine 50 mg in 0.9% Sodium Chloride 5 mL PCA, 50 mL Cartridge, Concentrati... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Fentanyl 10 mcg in 0.9% Sodium Chloride 1 mL, 1 mL Vial, Concentration: 10 mc... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Neostigmine Methylsulfate 5 mg/5 mL, 5 mL Syringe, Concentration: 1 mg/mL. T... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Succinylcholine chloride 100 mg in 5 mL syringe, Concentration: 20 mg/mL. Th... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Neostigmine Methylsulfate (single dose syringe) 1 mg per mL 5 mg per 5 mL Inj... Stability Date Doesn't Support Expiry: labeling error indicating a beyond use date that exceeds c... Class II Premier Pharmacy Labs Inc
Aug 10, 2017 Amoxicillin and Clavulanate Potassium for Oral Suspension, USP, 250/62.5 mg p... Presence of Foreign Substance: customer complaint of blue foreign material identified as a portio... Class II Morton Grove Pharmaceuticals, Inc.
Aug 10, 2017 Phenylephrine 1000 mcg in 0.9% Sodium Chloride 10 mL, 10 mL syringe, Concentr... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 10, 2017 Oxytocin 30 units in 0.9% Sodium Chloride 500 mL, 500 mL IV Bag, Concentratio... Lack of sterility assurance: Microbial growth detected during a routine simulation of the manufac... Class II SSM Health Care St. Louis DBA SSM St. Clare Hea...
Aug 4, 2017 Povidone Iodine, USP Prep Solution, 10%, packaged in 1 gallon bottle, OTC, Ma... Labeling: Label mix-up. Finished product Povidone iodine 7.5% was labeled as Povidone iodine 10% ... Class II Degasa Sa De Cv
Aug 4, 2017 Procrit Epoetin Alfa 40,000 units/mL single use vial For Intravenouse or Subc... Presence of particulate matter: Visible glass flakes identified as lamellae in some drug product ... Class II Amgen, Inc.
Aug 3, 2017 Vitamin A&D Ointment (petroleum 93.5%), Skin Protectant, NET Wt. 0.18 OZ (5g)... Labeling Mixup; the individual A&D ointment foil packets are incorrectly labeled as petroleum jel... Class II MEDLINE INDUSTRIES INC
Aug 2, 2017 Rugby Diocto Syrup, Docusate Sodium 60 mg/15 mL, Stool Softener Laxative, One... Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... Class II The Harvard Drug Group
Aug 2, 2017 Rugby Diocto Liquid, Docusate Sodium 50 mg/ 5 mL, Stool Softener Laxative, On... Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... Class II The Harvard Drug Group
Aug 2, 2017 Rugby Aller-chlor (Chlorpheniramine Maleate Syrup, USP), 2 mg, 4 fl. oz. (120... Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... Class II The Harvard Drug Group
Aug 2, 2017 Major Senna Syrup Natural Vegetable Laxative, Sennoside 8.8 mg, 8 fl. oz. (23... Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... Class II The Harvard Drug Group
Aug 2, 2017 Rugby Senexon Liquid Natural Vegetable Stimulant,(Sennosides) 8.8 mg, 8 fl o... Microbial contamination of Non-sterile Products; presence of yeast and potential B. cepacia conta... Class II The Harvard Drug Group
Jul 28, 2017 Famotidine USP 20 mg, 30 tablets bottle, Rx, PKG By; PD Rx Pharmaceuticals In... Failed Tablet/Capsule Specification: out of specification for tablet weight. Class II PD-Rx Pharmaceuticals, Inc.
Jul 26, 2017 Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Si... Presence of Particulate Matter: Silicone oil Class II HOSPIRA INC, LAKE FOREST
Jul 26, 2017 0.9% Sodium Chloride Injection, USP in 1000 mL Single Dose Flexible Container... Presence of Particulate Matter; stainless steel Class II ICU Medical Inc
Jul 26, 2017 Hydromorphone Hydrochloride Injection, USP, 500 mg/50 mL (10 mg/mL), 50 mL Si... Presence of Particulate Matter: Silicone oil Class II HOSPIRA INC, LAKE FOREST
Jul 26, 2017 Hydromorphone Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Singl... Presence of Particulate Matter: Silicone oil Class II HOSPIRA INC, LAKE FOREST
Jul 24, 2017 Famotidine Tablets USP, 20 mg, 100 count bottles, Rx only, Manufactured For:... Failed Tablet/Capsule Specification; out of specification for tablet weight Class II Teva Pharmaceuticals USA
Jul 20, 2017 Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for... Failed Impurities/Degradation Specification: single unknown impurity OOS 0.33% (Limit:NMT 0.20%W/... Class II Hetero USA Inc
Jul 17, 2017 Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bott... Microbial contamination of non-sterile products: product was found to contain mold, identified as... Class II Vi-Jon, Inc.
Jul 14, 2017 PHENYLephrine 40 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceutic... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Phenylephrine HCL in 0.9% Sodium Chloride 10 mL, 1 mg/10 mL (100 mcg/mL) Sing... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 PHENYLephrine HCl 60 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 20 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 Ephedrine Sulfate in 0.9% Sodium Chloride 5 mL, 50 mg/5 mL (10 mg/mL) Single... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 Glycopyrrolate Injection Solution, 5 mL 1 mg/5 mL (0.2 mg/mL) Single-Dose Syr... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride 250 mL Bag, Rx on... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL 2 mcg/mL + Ropivacaine 0.2% PF in NS 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 200 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceuti... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Diltiazem 125 mg in 0.9% Sodium Chloride, 1 mg per mL, Total Volume 125 mL Si... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... Class II SCA Pharmaceuticals
Jul 14, 2017 Neostigmine Methylsulfate Injection Solution 5 mL, 5 mg/5 mL (1 mg/mL) Single... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 fentaNYL 2 mcg/mL+Bupivacaine 0.0625% PF in 0.9% Sodium Chloride 250 mL, Rx o... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL (as citrate) 5 mcg/mL In 250 mL 0.9% Sodium Chloride Injection Bag ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 BUPIVacaine HCl 0.125% In 250 mL 0.9% Sodium Chloride Bag, Preservative Free ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Rocuronium Bromide Injection Solution 5 mL, 50 mg/5 mL (10 mg/mL) Single-Dose... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 fentaNYL (as citrate) 10 mcg per mL in 0.9% Sodium Chloride, (Total fentaNYL... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... Class II SCA Pharmaceuticals
Jul 14, 2017 ceFAZolin 3 g added to 100 mL 0.9% Sodium Chloride, Total Approximate Volume ... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... Class II SCA Pharmaceuticals
Jul 14, 2017 Glycopyrrolate Injection Solution, 1 mL 0.2 mg/1 mL (0.2 mg/mL) Single-Dose S... Lack of Sterility Assurance. Class II Cantrell Drug Company
Jul 14, 2017 fentaNYL 2 mcg/mL + BUPIvacaine 0.125% PF in 0.9% Sodium Chloride 250 mL, Rx ... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL 10 mcg/mL PF in NS 1 mL Fill in 3 mL syringe, Rx only, SCA Pharmaceu... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 PHENYLephrine 50 mg in 0.9% Sodium Chloride 250 mL, Rx only, SCA Pharmaceutic... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 fentaNYL 2 mcg/mL + BUPIvacaine 0.1% PF in 0.9% NS 250 mL, Rx only, SCA Pharm... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 Hydromorphone 0.5 mg/mL in 0.9% Sodium Chloride 1 mL Fill in 3 mL BD syringe,... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals
Jul 14, 2017 MAGNESIUM Sulfate 4 g added to 100 mL 0.9% Sodium Chloride, Total Approximate... Lack of Assurance of Sterility: Product made with recalled 0.9% sodium chloride bags which have t... Class II SCA Pharmaceuticals
Jul 14, 2017 PHENYLephrine HCl 10 mg in 0.9% Sodium Chloride 250 mL Bag, Preservative Free... Lack of Assurance of Sterility; product has the potential to leak. Class II SCA Pharmaceuticals

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.