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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

6,274 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,274 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 6,274 FDA drug recalls.

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DateProductReasonClassFirm
Apr 20, 2016 Magnesium Sulfate 1GM Added to 0.9% Sodium Chloride, 50 mL bag, Rx only, Com... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Oxytocin 30 Units added to Lactated Ringers in a 500 mL lntravia bag, Rx Only... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 25mcg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Monoj... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Provocholine pre-diluted in 0.9% Sodium Chloride Set II syringes, 0.0625mg/m... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Epinephrine 100mcg/mL injection in 0.9% Sodium Chloride 10 mL BD syringe, Rx... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 HYDROmorphone HCI 0.4mg/ml in 0.9% Sodium Chloride, 30 mL PCA Vial, Rx Only, ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Morphine Sulfate 5mg/mL in 0.9% Sodium Chloride 25 mL fill in a 30 mL BD Syri... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Methohexital (Brevital Sodium) 10 mg/mL,10 mL syringe, Rx Only, Compounded by... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Adenosine 1mg/ml (PF) in 0.9% Sodium Chloride (Total 90 mg/90 ml in 100 mL PA... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Norepinephrine Bitartrate 4 mg (16mcg/mL) added to 5% Dextrose, 250 mL bag;,... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ondansetron 2mg/mL, 2 mL fill in a 3 mL syringe, Rx Only, Compounded by PHARM... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Hydromorphone HCI 0.2mg/mL in 0.9% Sodium Chloride 50 mL Cadd Cassette (grey... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Phenylephrine HCI 40mg/250 mL in 0.9% Sodium Chloride 250 mL bag, Rx Only, Co... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Hydromorphone HCI 0.4mg/mL in 0.9% Sodium Chloride 30 mL fill in a 35 mL Mono... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 25 mcg/mL in 0.9% Sodium Chloride 25 mL in 30 mL syringe, Rx... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 2 mcg/mL & Bupivacaine HCL 0.125 % in 0.9% Sodium Chloride, ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Phenylephrine 40 mcg/mL injection in 0.9% Sodium Chloride 10 mL syringe, Rx O... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 2mcg/mL & Bupivacaine 0.125% in 0.9% Sodium Chloride 150 mL ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Morphine Sulfate (PF) 1mg/mL in 0.9% Sodium Chloride, 50 mL lntravia Bag IV U... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Cefazolin 3GM Added to a 100 mL 0.9% Sodium Chloride Bag, Rx Only, Compounded... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 5 mcg/mL & Bupivacaine 0.06% in 0.9% Sodium Chloride, 60 mL ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Cefazolin 1GM in Sterile Water, 10 ml BD syringe, Rx Only, Compounded by PHAR... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Magnesium Sulfate 50 GM in Lactated Ringers 500 mL bag; Rx Only, Compounded b... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 HYDROmorphone 1mg/mL in 0.9% Sodium Chloride 1 mL fill in a 3 mL syringe, Rx ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Fentanyl Citrate 2mcg/mL & Ropivacaine HCI 0.2% in 0.9% Sodium Chloride, 100 ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Midazolam HCI1mg/mL in 0.9% Sodium Chloride 100 mL fill in a 150 mL lntravia ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Oxytocin 30 Units added to 0.9% Sodium Chloride in a 500 mL lntravia bag, Rx ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Rocuronium 10 mg/mL, 5 mL syringe, Rx Only, Compounded by PHARMAKON Pharmaceu... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Bupivacaine HCI 0.25% in 0.9% Sodium Chloride, 500 mL Intravia bag, Rx Only,... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Potassium Chloride 40 mEq Added to 0.9% Sodium Chloride 250 mL bag, Rx Only, ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Sufentanil Citrate 0.4mcg/mL & Bupivacaine 0.1% in 0.9% Sodium Chloride 250 ... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Oxytocin 20 Units added to 0.9% Sodium Chloride in a 1000mL lntravia bag, Co... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Promethazine 12.5mg added to 0.9% Sodium Chloride 50 mL fill in a 100 mL B/Br... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Cefazolin 2GM added to 5% Dextrose 50 mL USP, Rx Only, Compounded by PHARMAKO... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ketamine 50mg/mL in 0.9% Sodium Chloride 1mL fill in 3 mL syringe, Rx Only, C... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 HYDROmorphone HCI 0.2 mg/mL in 0.9% Sodium Chloride 50 mL fill in a 60 mL Mon... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Ketamine 20 mg/mL in 0.9% Sodium Chloride, 50 mL lntravia bag, Rx Only, Compo... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 20, 2016 Succinylcholine Chloride 20 mg/mL, 10 mL BD syringe, Rx Only, Compounded by P... Lack of Assurance of Sterility Class II Pharmakon Pharmaceuticals, Inc.
Apr 18, 2016 Vancomycin 1750 mg in 270 mL 0.9% NS bag,FOR IV USE ONLY, Baptist Health Medi... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Vancomycin 1000 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Med... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Ertapenem 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bag, FOR IV U... Lack of Sterility Assurance. Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 0.9% Sodium Chloride a) 500 mL b) 2000 mL and c) 3000 mL bags, FOR IV USE ONL... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Ceftriaxone 1 gram Add-Vantage in a) 50 mL and b) 100 mL 0.45% NS bags, FOR I... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Remicade 600 mg in 250 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medica... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Nafcillin 3 grams in 277 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medi... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Cefazolin 6 grams in 292 mL 0.9% NS bags, FOR IV USE ONLY, Baptist Health Med... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 TPN 2, (amino acid 20%) 2000 ml bag (140), FOR IV USE ONLY, Baptist Health Me... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Daptomycin 650 mg in 50 mL 0.9% NS bag, FOR IV USE ONLY, Baptist Health Medic... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Piperacillin-Tazobactam 10.125 grams/NS 307 mL BAG, FOR IV USE ONLY, Baptist ... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...
Apr 18, 2016 Piperacillin-Tazobactam 13.5 grams/NS 322 mL bag, FOR IV USE ONLY, Baptist He... Lack of Sterility Assurance Class II Baptist Health Medical Towers Pharmacy and Infu...

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.