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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

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 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 6,306 FDA drug recalls.

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DateProductReasonClassFirm
Feb 22, 2023 Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 8 mg/250 mL... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 4 mg/250 mL... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Diltiazem HCl in 0.7% Sodium Chloride Injection, 125 mg/125 mL (1 mg/mL), 125... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 m... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 22, 2023 Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection, USP, 16 mg/250 m... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Feb 14, 2023 Purely Soothing 15% MSM Drops, packaged in a)15 ml, .5 fl oz bottle, UPC 7 31... Non-Sterility Class I Pharmedica USA, LLC
Feb 10, 2023 0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B... Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP ... Class II B. Braun Medical Inc.
Feb 10, 2023 0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B.... Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP ... Class II B. Braun Medical Inc.
Feb 8, 2023 Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0... Lack of assurance of sterility: Suspected microbial growth present on external label packaging. Class II Apollo Care
Feb 3, 2023 Abelcet (Amphotericin B Lipid Complex) Injection, 5 mg/mL, 100 mg vial, Rx on... Lack of assurance of sterility: Medial fill with presence of Cupriavidus pauculus. Class II Leadiant Biosciences, Inc.
Jan 30, 2023 Delsam Pharma's ARTIFICIAL TEARS (Carboxymethylcellulose Sodium) Lubricant Ey... Non-Sterility: FDA analysis found unopened products to have bacterial contamination. Class I Global Pharma Healthcare Private Limited
Jan 30, 2023 Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG i... Non-Sterility: FDA analysis found unopened products to have bacterial contamination. Class I Global Pharma Healthcare Private Limited
Jan 6, 2023 Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), 5 x 5 mL Pre-Filled Syri... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
Dec 30, 2022 Prostaglandin (E1) Injection Solution, 10 mcg/ml, packaged in 2.5 mL Multiple... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Super 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Standard 001 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Plus 001 (PGE1/Papaverine HCl/Phentolamine Mesylate) 20mcg/30mg/2mg/mL... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 BiMix Injection (Papaverine HCl/Phentolamine Mesylate) 30mg/0.5mg/mL INJECTAB... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 30mcg/60mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 40mcg/30mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Standard 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 10m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Plus 002 (PGE1/Papaverine HCl/Phentolamine Mesylante) 25mcg/30mg/2mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Super 002 (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 40mcg/... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Prostaglandin (E1) Injection Solution, 25mcg/ml, 2.5 mL Multiple-Dose vials, ... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine) 100mcg/30mg/2mg/mL INJECT... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 100mcg/30mg/3mg/... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Mitomycin Injection Solution, 4mg/ml, packaged in a 10 mL Multiple-Dose vial,... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 10mcg/20mg/1mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Original (PGE1/Papaverine HCl/Phentolamine Mesylate) 5.88mcg/18mg/0.6m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Prostaglandin (E1) Injection Solution, 40mcg/ml, 2.5 mL Multiple-Dose vials, ... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Prostaglandin (E1) Injection Solution, 20 mcg/ml, 2.5 mL Multiple-Dose vials,... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 BiMix STD 001 (Papaverine HCl/Phentolamine Mesylate) 30mg/1mg/mL INJECTABLE, ... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Injectable (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 50mcg... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 Methylcobalamin Injection Solution, 12.5mg/ml, packaged in 2 mL Multiple-Dose... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 11.8mcg/18mg/0.6... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 TriMix Injection (PGE1/Papaverine HCl/Phentolamine Mesylate) 60mcg/30mg/3mg/m... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 30, 2022 QuadMix Plus (PGE1/Papaverine HCl/Phentolamine Mesylate/Atropine) 20mcg/30mg/... Lack of Assurance of Sterility Class II Northern VA Compounders PLLC
Dec 29, 2022 Heparin Sodium 2,000, USP Units, per 1,000 mL (2 USP Units/mL) in 0.9% Sodium... Lack of assurance of sterility: Bags have the potential to leak. Class II Pfizer Inc.
Dec 27, 2022 INTRALIPID 18GM, TPN, Rx Only, use with a Curlin pump, Sentara Home Infusion ... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 Amikacin 450MG IN NS 45ML, Antibiotic, used in a HOMEPUMP, Sentara Home Infus... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 AMPICILLIN 12GM IN NS 600M, used with a Curlin pump, Sentara Home Infusion Ph... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 TPN (a) 115GM/AA, 215GM/DEX, 25GM/LIP 1150ML, (b)90GM/AA, 215GM/DEX, 25GM/LIP... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 DAPTOMYCIN (a) 400MG IN NS 20ML, (b) 550MG IN NS 27.5ML, antibiotic, Rx only,... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 ETHANOL 70% 0.5ML SYRINGE, Cathcare, Sentara Home Infusion Pharmacy Services,... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 Diphenhydramine 18mg in 3.6ML NS SYRINGE, antihistamine, Rx Only, Sentara Hom... Lack of sterility assurance Class II Sentara Infusion Services
Dec 27, 2022 CEFTRIAXONE (a) 1GM IN NS 50ML, (b)4GM IN NS 200ML, (c) 8GM IN NS 400ML, anti... Lack of sterility assurance Class II Sentara Infusion Services

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.