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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.

Clear
DateProductReasonClassFirm
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 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 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 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 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 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 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 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 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 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 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 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 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 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 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 14, 2019 Losartan Potassium, 100 mg tablets, 90 count bottle, NDC 60429-318-90 CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Golden State Medical Supply Inc.
Jun 14, 2019 Losartan Potassium, 50 mg tablets, 90 count bottle, NDC 60429-317-90 CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Golden State Medical Supply Inc.
Jun 14, 2019 Losartan Potassium, 50 mg tablets, 1000 count bottle, NDC 60429-317-10 CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Golden State Medical Supply Inc.
Jun 14, 2019 Losartan Potassium, 50 mg tablets, 30 count bottle, NDC 60429-317-30 CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the activ... Class II Golden State Medical Supply Inc.
Jun 13, 2019 Heparin Sodium 25,000 USP units per 250 mL (100 USP units per mL) in 5% Dextr... Subpotent Drug: low out-of-specification results were identified for the drug anti-factor IIa pot... Class II B. Braun Medical Inc
Jun 13, 2019 Sevoflurane, USP Inhalation Anesthetic 250 mL bottles, Rx only, Manufactured ... Failed Stability Specifications Class II Baxter Healthcare Corporation
Jun 12, 2019 Durvalumab 651 mg/ 250 ml NS IVPB; Durvalumab 650 mg/ 250 ml NS IVPB, Rx Only... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 IRON SUCROSE 200 mg / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 BORTEZOMIB 2.5 mg / 1 ML SQ SYRINGE; BORTEZOMIB 2.88 MG / 1.15 ML SQ SYRINGE;... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 RITUXAN 728 MG QS 728 mL 0.9% NACL IVPB; RITUXAN 560 MG / 306 ml 0.9% NACL;... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Doxorubicin Liposomal 71 MG / 250 ML D5W IVPB; Doxorubicin Liposomal 66 MG/25... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 ERBITUX 770 MG/ 385 ML IVPB; ERBITUX 440 MG/ 220 ml IVPB; ERBITUX 850 MG/ ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 METHYLPREDNISOLONE 10 MG / 0.16 ML IVP, Rx Only, Infusion Options, Inc. 5924 ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 VINBLASTINE 10.9 MG / 100 ML D5W IVPB; VINBLASTINE 10.8 MG / 100 ML D5W IVPB,... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 DARATUMUMAB 904 MG QS 500 ML NS IVPB; DARATUMUMAB 668 MG QS 1000 ML NS IVPB, ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 ALIMTA 785 mg QS 100 ml 0.9% NACL IVPB; ALIMTA 1000 mg QS 100 ml 0.9% NACL IV... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 PERTUZUMAB 840 MG/250 ml0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924 ... 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 ONDANSETRON 8 MG / 50 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 MITOMYCIN 10 MG /20 ML IVP SYRINGE, Rx Only, Infusion Options, Inc. 5924 13th... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 BLEOMYCIN 18 UNITS / 100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13t... Lack of Assurance of Sterility Class II Infusion Options, 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 NIVOLUMAB 480 MG / 100 ML NS IVPB; NIVOLUMAB 200 mg / 100 ML NS IVPB; NIVOLUM... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 AZACITIDINE 125 MG / 5 ML SUB-Q SYRINGE; AZACITIDINE 75 MG (3 ML) SYRINGE, AZ... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 RITUXIMAB 575 MG / 250 ml 0.9% NACL IVPB; RITUXIMAB 675 MG / 250 ml 0.9% NACL... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 ORENCIA 750 mg QS 100 ml 0.9% NACL IVPB, Rx Only, Infusion Options, Inc. 5924... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 PANITUMUMAB 400 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13t... 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 Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Inf... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 CARBOPLATIN 174 MG / 250ml NS IVPB; CARBOPLATIN 240 MG / 250 ML NS IVPB; CARB... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 Fluorouracil 560 MG / 11.2 ML IVP; Fluorouracil 3340 MG QS 92 ML 0.9% NACL; F... Lack of Assurance of Sterility Class II Infusion Options, Inc.
Jun 12, 2019 DECITABINE 40 MG / 100 ml NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the... 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.