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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

1,344 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,344 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 1,344 FDA drug recalls in IL.

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DateProductReasonClassFirm
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 12, 2017 Halyard 24-Hour Oral Care Kit q4, contains 2x15 mL Unit Dose Cups 0.12% Chlor... Crystallization with subpotent out of specification assay results for chlorhexidine. Class III Akorn Inc
Jul 12, 2017 Chlorhexidine Gluconate Oral Rinse, 0.12%, 15 mL Unit Dose Cup, a) unit dose ... Crystallization with subpotent out of specification assay results for chlorhexidine. Class III Akorn Inc
Jul 12, 2017 Halyard 24-Hour Oral Care Kit q2, contains 2x15 mL Unit Dose Cups 0.12% Chlor... Crystallization with subpotent out of specification assay results for chlorhexidine. Class III Akorn Inc
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 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 Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 5 mL Single-use vial, Rx Onl... Failed Impurities/Degradation Specifications; out of specification result for denitroquinoline-re... Class III Hospira Inc., A Pfizer Company
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 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 1, 2017 Chlorhexidine Gluconate 0.12% Oral Rinse, USP, 1 Pint (473 ml), Rx Only, Dis... CGMP Deviations Class II Xttrium Laboratories Inc
May 22, 2017 Caffeine Powder, Anhydrous, Pharmaceutical Grade, 100% Pure caffeine, 250 g (... Marketed without an Approved NDA/ANDA: The product consists of pure, powdered caffeine and is an... Class II Global Marketing Enterprises, Inc.
May 18, 2017 Levophed norepinephrine bitartrate, injection, USP, 4 mg /4 mL (1 mg/mL),Rx o... GMP Deviation; A foreign stopper was observed during packaging of a lot of product. Class II Hospira Inc., A Pfizer Company
May 15, 2017 Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav... Lack of assurance of sterility: customer complaints received for the presence of leaks. Class II Baxter Healthcare Corporation
May 15, 2017 Milrinone Lactate in 5% Dextrose Injection, 20 mg/100 mL, 100 mL Single-Dose ... Lack of assurance of sterility: customer complaints received for the presence of leaks. Class II Baxter Healthcare Corporation
Apr 21, 2017 Infant 25% DEXTROSE Injection, USP, 2.5 g (250 mg/mL), 10 mL Unit of Use Sing... Presence of Particulate Matter: human hair found within an internal sample syringe. Class I Hospira Inc.
Apr 20, 2017 IC-Green (indocyanine green for injection, USP), 25 mg, packaged in a kit con... Product is being recalled due to low pH value. Class III Akorn, Inc.
Mar 21, 2017 Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) p... Microbial Contamination of Non-Sterile Products: potential of an elevated bioburden with identifi... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Mar 17, 2017 LATANOPROST OPHTHALMIC SOLUTION, 0.005%, 125 ug/2.5 mL, packaged in 2.5 mL b... Lack of assurance of sterility: product was found to be empty, under-filled, or leaking. Class II Akorn, Inc.
Mar 16, 2017 Fluphenazine Decanoate Injection, USP; 25 mg/mL, 5mL vials, Rx only, APP Phar... Subpotent Drug Class III Fresenius Kabi USA, LLC
Mar 13, 2017 Sulfamethoxazole and Trimethoprim Oral Suspension, USP 200 mg / 40 mg per 5 m... Failed Dissolution Specifications Class II Akorn Inc
Feb 17, 2017 Potassium PHOSphate added to 0.9% Sodium Chloride, 20 mMol 100 mL Bag, Servic... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class III Pharmedium Services, LLC
Feb 17, 2017 VANCOMYCIN HCl 1.5g in 300 mL 0.9% Sodium Chloride Injection USP, Service Cod... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class II Pharmedium Services, LLC
Feb 17, 2017 Potassium PHOSphate added to 0.9% Sodium Chloride, 15 mMol 100 mL Bag, Servic... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class III Pharmedium Services, LLC
Feb 17, 2017 Potassium PHOSphate in 0.5% Dextrose, 7.5 mMol in 100 mL, Service Code 2K5299... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class II Pharmedium Services, LLC
Feb 17, 2017 Potassium CHLORide added to 0.9% Sodium Chloride, 10mEq 100 mL Bag, Service C... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class III Pharmedium Services, LLC
Feb 17, 2017 Potassium PHOSphate added to 0.9% Sodium Chloride, 10 mMol 100 mL Bag, Servic... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class III Pharmedium Services, LLC
Feb 17, 2017 Potassium CHLORide added to 0.9% Sodium Chloride, 30mEq 100 mL Bag, Service C... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class III Pharmedium Services, LLC
Feb 17, 2017 VANCOMYCIN HCl 1.75g in 300 mL 0.9% Sodium Chloride Injection USP, Service Co... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class II Pharmedium Services, LLC
Feb 17, 2017 Potassium PHOSphate added to 0.9% Sodium Chloride, 7.5 mMol 100 mL Bag, Servi... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class III Pharmedium Services, LLC
Feb 17, 2017 VANCOMYCIN HCl 1.5g in 300 mL 5% Dextrose Injection USP, Service Code 2K2227,... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class II Pharmedium Services, LLC
Feb 17, 2017 Potassium PHOSphate added to 0.9% Sodium Chloride, 7 mMol 100 mL Bag, Service... Labeling: Not Elsewhere Classified: Incorrect volume printed on the product label. Class III Pharmedium Services, LLC
Feb 15, 2017 Ropivacaine HCl 0.2% 550 mL Total Volume in an AutoFuser Pump in 0.9% Sodium ... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Pharmedium Services Llc
Feb 15, 2017 Bupivacaine HCl 0.25% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlo... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Pharmedium Services Llc
Feb 15, 2017 Bupivacaine HCl 0.25% 270 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlo... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Pharmedium Services Llc
Feb 15, 2017 Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Pharmedium Services Llc
Feb 15, 2017 Ropivacaine HCl 0.2% 750 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Pharmedium Services Llc
Feb 15, 2017 Ropivacaine HCl 0.2% 500 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Pharmedium Services Llc
Feb 15, 2017 Ropivacaine HCl 0.2% 400 mL Total Volume in an ON-Q Pump in 0.9% Sodium Chlor... Labeling: Incorrect or Missing Lot and/or Exp Date Class III Pharmedium Services Llc
Feb 10, 2017 METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible ... Lack of Sterility Assurance: customer report of leaking bag Class II Hospira Inc., A Pfizer Company
Feb 2, 2017 Q Care Continue Care Kit for the non-ventilated patient; kit contains 1 Cover... Labeling: Incorrect or Missing Lot and/or Exp Date: The expiration date of the Q Care Continue Ca... Class III Sage Products Inc
Jan 27, 2017 Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactur... Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jan 27, 2017 Buffered Lidocaine, 1%, In Sodium Bicarbonate 8.4%, 1 mL Total Volume in a 3 ... Labeling; Label Mixup; outer packaging is incorrectly labeled as Buffered Lidocaine 1% instead of... Class III Pharmedium Services, LLC
Jan 24, 2017 Vancomycin Hydrochloride for Injection, USP, 10 grams, Pharmacy Bulk Package ... Presence of Particulate Matter: A hair was found stuck to the stopper of inside a single vial. Th... Class I Hospira Inc., A Pfizer Company
Jan 13, 2017 Duopa (carbidopa and levodopa enteral suspension), 4.63 mg/20 mg per mL, 100 ... Failed Stability Specifications: confirmed out of specification results obtained during refrigera... Class II AbbVie Inc.
Dec 16, 2016 MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per c... Failed Impurities/Degradation Specifications Class II Fresenius Kabi USA, LLC
Dec 7, 2016 Novacort Gel Sample Packets (2% hydrocortisone acetate, 1% pramoxine HCl), 10... Subpotent Drug: Out of specification result for pramoxine hydrochloride Class III Novum Pharma, LLC
Dec 6, 2016 Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav... Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. Class II Baxter Healthcare Corporation
Dec 6, 2016 10% Premasol sulfite-free (Amino Acid) Injection, 2000 mL bulk package, Rx on... Discoloration: there were customer reports of yellow discolored solution. The yellow coloration i... Class II Baxter Healthcare Corporation
Nov 14, 2016 Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60... Failed Stability Specifications; out-of specification value for homogeneity / phase separation. Class II Akorn Inc
Nov 1, 2016 Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/m... Lack of Assurance of Sterility: Complaints of broken tips on the ampules. Class II Hospira 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.