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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

6,322 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,322 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 6,322 FDA drug recalls.

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DateProductReasonClassFirm
Jun 19, 2019 MIC (METHIONINE/INOSITOL/CHOLINE CHLORIDE) 25/50/50 MG/ML INJ, 30 ML per vial... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 SODIUM BICARBONATE 8.4% (1 MEQ/ML) INJ SOLN (PFV), 50 ML PER VIAL, RXQ Compou... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MANGANESE SULFATE MONOHYDRATE (PFV) 0.1MG/ML INJ, 10 ML per syringe, RXQ Comp... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 TURBO DROPS (PHEN 2.5% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per d... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 EPINEPHrine 1:1000 INJECTION SOLUTION (PF) Syringe, 1 ML per syringe, RXQ Com... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 PYRIDOXINE (PFV) 100MG/ML, 30ML PER VIAL. RXQ Compounding, 340 West State Str... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 LIDOCAINE HCL 2% INJECTION SOLUTION (NPV), 20ML per vial, RXQ Compounding, 34... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 Copper 0.4MG/ML (PVF) INJECTION SOLUTION, 10 ML per vial, RXQ Compounding, 34... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 TURBO DROPS (PHEN 10% / CYCLO 1%/ TROP 1%/ KETO 0.5%) OPHTH SOLN, 5 ML per dr... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 MIDAZOLAM 1MG/ML IN NACL 0.9% INJ SOL SYR (C-IV), 10 ML per syringe, RXQ Comp... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 RIBOFLAVIN 0.1% OPHTHALMIC SOLUTION SYRINGE, 2 ML per syringe. RXQ Compoundin... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 METHYLCOBALAMIN (PFV) 10 MG/ML INJECTABLE, 10 ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 CALCIUM CHLORIDE 100MG/ML (PFV) INJ SOLN, 10 ML per vial, RXQ Compounding, 34... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 diazePAM 5 MG/ML INJECTION SOLUTION (C-IV) SYR, 2 ML per syringe, RXQ Compoun... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 HYDROXOCOBALAMIN 1000 MCG/ML (MDV), 30 ML per vial, RXQ Compounding, 340 West... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 POTASSIUM CHLORIDE 15% (2MEQ/ML) INJ SOLN, 30 ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 KETAMINE 10 MG/ML INJ SOL SYR (C-III), [a) 2 ML NDC: 70731-0132-02; b) 5 ML N... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 VITAMIN B COMPLEX 100 (PFV), [2 or 30 ML] per Vial, RXQ Compounding, 340 West... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 TURBO CAINE 2.5 (PHEN2.5/CYCLO1/ TROP1/TETRA 0.5), 0.4 ML per Syringe, RXQ Co... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 EPHEDRINE 5MG/ML (PF) SYRINGE, 5 ML per syringe, RXQ Compounding, 340 West St... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 19, 2019 DEXTROSE 50% INJECTION SOLUTION (PF) VIAL, 50 ML per vial, RXQ Compounding, 3... Lack of Assurance of Sterility Class II RXQ Compounding LLC
Jun 18, 2019 SUCCINYLcholine Chloride, 200mg/10mL (20mg/mL), 10mL Sterile Single Dose Syri... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Naloxone HCL Preserved INJ, 500mg/50mL (10mg/mL), 50mL Sterile MDV, Rx only, ... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Mitomycin Preservative Free Irrigation, 40mg/10mL (4mg/mL), 10mL SDV, Rx only... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Orphenadrine Citrate Sterile Injectable Solution *Contains Sulfites*, 30mg/mL... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Lidocaine 0.5%/Phenylephrine 0.75% P.F. INJ, 1mL Sterile SDV, Rx only, Premie... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Sing... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Dexamethasone Sodium Phosphate Preservative Free Sterile Solution for INJ, 24... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Phenylephrine HCL PF INJ in 0.9% Sodium Chloride, 1000mcg/10mL (100mgc/mL), *... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premie... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Isoproterenol HCL in D5W (Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL St... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Riboflavin 5-Phosphate Sodium Ophthalmic Solution, 19.05mg/3mL (6.35 mg/mL), ... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Neostigmine Methylsulfate, 5mg/5mL (1mg/mL), 5mL Single Dose Syringe, Rx only... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Sodium Bicarbonate INJ 8.4%, 50 mEq/50mL (84mg/mL) (1mEq/mL), 50mL Sterile SD... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Isoproterenol HCL in D5W, 500mcg/50mL (10mcg/mL), 50mL Sterile Single-Dose Ba... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SD... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50m... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 18, 2019 SUCCINYLcholine Chloride, 100mg/5mL (20mg/mL), 5mL Sterile Single-Use Syringe... Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potenti... Class II Premier Pharmacy Labs Inc
Jun 12, 2019 RomiPLOStim 700 MCG/ 1.4 ML SQ SYR, Rx Only, Infusion Options, Inc. 5924 13th... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 ERIBULIN 1.12 MG / 100 ML NS IVPB; ERIBULIN 1.87 MG / 100 ML NS IVPB; ERIBUL... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 IFOSFAMIDE 9200 MG / 1 L NS IVPB WITH MESNA 9200 MG, Rx Only, Infusion Option... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Gemcitabine 1910 MG / 250 ML NS IVPB; Gemcitabine 1140 MG / 250 ML NS 0.9% IV... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 DIPHENHYDRAMINE 25 MG/50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the Av... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 FOSAPREPITANT 150 mg/150 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13t... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 METHOTREXATE 25 MG / 1 ML IM SYR; METHOTREXATE 12 mg QS 5 ml PF 0.9% NACL; ME... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 DARZALEX 1008 MG / 500 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 GAZYVA 100 MG IN 250 ML NS IVPB; GAZYVA 900 MG IN 250 ML NS IVPB, Rx Only, In... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 GRANISETRON 1000 MCG / 50 ML NS, Rx Only, Infusion Options, Inc. 5924 13the A... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 CARFILZOMIB 65 MG IN 50 ML D5W IVPB; CARFILZOMIB 75 MG IN 50 ML D5W IVPB; CAR... Lack of Assurance of Sterility Class II Infusion Options, 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.