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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.

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DateProductReasonClassFirm
Dec 6, 2021 Phenylephrine HCl, Sterile Solution for Injection, (PF), 800 mcg/10mL (80 mcg... Lack of Assurance of Sterility Class II Edge Pharma, LLC
Dec 3, 2021 Methylcobalamin 12mg/ml injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape... Lack of Processing Controls Class II Valgene Incorporated dba Cape Drugs
Dec 3, 2021 B-Complex, injection, 1 mL vials, Rx only, Cape Drugs 1384 Cape St. Claire Ro... Lack of Processing Controls Class II Valgene Incorporated dba Cape Drugs
Dec 2, 2021 Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufa... Failed Dissolution Specifications Class II Torrent Pharma Inc.
Nov 30, 2021 Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 ... Superpotent Drug: Minimally superpotent Class II Teligent Pharma, Inc.
Nov 30, 2021 5% Dextrose Injection, USP, 50 mL ADD-Vantage Unit, Rx only, Distributed by H... Lack of sterility assurance: bag has the potential to leak. Class II Pfizer Inc.
Nov 29, 2021 Diclofenac Sodium Topical Solution, 1.5% w/w, packaged in 150 mL bottles, Rx ... Defective container: Out of specification for container integrity leading to bottles leaking. Class II Preferred Pharmaceuticals, Inc.
Nov 29, 2021 PAIN AID ESF- (Acetaminopehn USP 250mg, Asprin USP 250mg Caffeine 65mg) coate... CGMP Deviations: failed stability results, inadequate laboratory investigations, Class II ULTRAtab Laboratories, Inc.
Nov 29, 2021 Moxifloxacin, 1 mg/mL, 1mL in 2mL vial, solution for intracameral injection, ... Labeling: Label Mix-up: Vials labeled as moxifloxacin 1 mg/mL may actually contain moxifloxacin 5... Class II Denver Solutions, LLC DBA Leiters Health
Nov 23, 2021 Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deod... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret, Dry Spray, Aluminum chlorohydrate 23.5% Antiperspirant, Waterlily, To... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret OUTLAST Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Pro... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Old Spice, SWEAT DEFENSE, STRONGER SWAGGER, Dry Spray, 48 Hour, (Aluminum Chl... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Old Spice Pure Sport 2021 Gift Set, Contains: Old Spice Pure Sport Body Wash ... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret, OUTLAST, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, C... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret, powder fresh, (Aluminum chlorohydrate 24%), Anti-Perspirant/Deodorant... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Old Spice, SWEAT DEFENSE PURE SPORT PLUS, (Aluminum Chlorohydrate 23.5%), Ant... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Ant... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Lavender, ... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 23, 2021 Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Light Esse... CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated ... Class II The Procter & Gamble Company
Nov 19, 2021 Hydrocodone Bitartrate and Acetaminophen Tablets, USP 10 mg/325 mg, 100-count... Product Mix-up Class II Ascent Pharmaceuticals, Inc.
Nov 17, 2021 Methylcobalamin Solution for Injection, 1 mg/mL, 30 mL Multiple Dose Vial, Fo... Lack of Assurance of Sterility Class II ASP CARES
Nov 17, 2021 Ascorbic Acid Solution for Injection, 500 mg/mL, 50 mL Multiple Dose Vial, Fo... Lack of Assurance of Sterility Class II ASP CARES
Nov 17, 2021 Biotin Solution for Injection, 10 mg/mL, 30 mL Multiple Dose Vial, Sterile, F... Lack of Assurance of Sterility Class II ASP CARES
Nov 12, 2021 PHENYLepherine HCL in 0.9% Sodium Chloride, 20 mg per 250 mL (80 mcg per mL),... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE 4 mg per 250 mL (16 mcg per mL) in 5% Dextrose Injection, Rx o... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 2.5 mg per 250 mL, (10 m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 8 mg per 250 mL (32 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHrine in 0.9% Sodium Chloride Injection, 16 mg per 250 mL (64 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHrine, 2 mg per 250 mL (8 mcg per mL) in 0.9% Sodium Chloride Injection... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 dilTIAZem HCl in 5% Dextrose Injection, 125 mg per 125 mL, (32 mcg per mL), R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 4 mg per 250 mL (16 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 PHENYLephrine HCl, 50 mg per 250 mL, (200 mg per mL) in 0.9% Sodium Chloride ... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 EPINEPHIrine in 0.9% Sodium Chloride Injection, 5 mg per 250 mL (20 mcg per m... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Morphine Sulfate in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg p... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE in 5% Dextrose Injection, 8 mg per 250 mL (32 mg per mL) Injec... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 MORPHINE SULFATE, in 0.9% Sodium Chloride Injection, 50 mg per 50 mL, (1 mg p... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Sodium Bicarbonate in 5% Dextrose Injection, Rx Only, SterRx, 141 Idaho Ave.,... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 4 mg per 250 mL, (18 mcg per mL) in 0.9% Sodium Chloride Inje... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Midazolam in 0.9% Sodium Chloride Injection, 100 mg per 100 mL (1 mg per mL),... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 5% Dextrose Injection, R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 dilTIAZem HCl 125 mg per 125 mL (1 mg per mL) in 0.7% Sodium Chloride Injecti... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Morphine Sulfate in 5% Dextrose Injection, 100 mg per 100 mL (1 mg per mL), R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Midazolam in 0.9% Sodium Chloride Injection, 50 mg per 50 mL (1 mg per mL), R... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 16 mg per 250 mL, (64 mcg per mL) in 0.9% Sodium Chloride Inj... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 NOREPINEPHRINE, 8 mg per 250 mL, (32 mcg per mL) in 0.9% Sodium Chloride Inje... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1000 mL (12.6 mg per... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Succinylcholine Chloride Injection, 200 mg per 10 mL (20 mg per mL), 1,000 mL... Lack of Assurance of Sterility Class II SterRx, LLC
Nov 12, 2021 Fentanyl Citrate, in 0.9% Sodium Chloride Injection, 1 mg per 100 mL, (10 mcg... Lack of Assurance of Sterility Class II SterRx, LLC

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.