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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

14,449 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,449 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 14,449 FDA drug recalls, Class II.

Clear
DateProductReasonClassFirm
Aug 14, 2023 All Over-The-Counter (OTC) drug products warehoused, salvaged, and sold by In... CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Al... Class II Inmar Supply Chain Solutions, LLC
Aug 11, 2023 DIANEAL Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution 1.5% Dextrose, p... Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Class II Baxter Healthcare Corporation
Aug 11, 2023 Sodium Fluoride 1.1%, SODIUM FLUORIDE Prescription Dental Toothpaste, 5000 pp... Cases of Sodium Fluoride 1.1% Prescription Dental Toothpaste may contain cartons labeled as Capsa... Class II AVKARE LLC
Aug 11, 2023 Dianeal PD-2 Peritonial Dialysis Solution with 1.5% Dextrose, 5000 mL AMBU-FL... Lack of Assurance of Sterility: Potential presence of leaks originating from the Luer component. Class II Baxter Healthcare Corporation
Aug 11, 2023 Capsaicin Cream 0.025%, External Analgesic Cream, Penetrating Pain Relief, NE... Product mix-up: Cartons labeled Capsaicin Cream 0.025% may contain tubes of Sodium Fluoride 1.1% ... Class II AVKARE LLC
Aug 10, 2023 hello wild strawberry fluoride toothpaste, sodium fluoride 0.24% (0.15% w/v f... Labeling: Label Mix-Up: Some hello wild strawberry fluoride toothpaste, packaged in cartons label... Class II Colgate Palmolive Company
Aug 9, 2023 YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, pa... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged ... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and pota... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% ... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bot... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 9, 2023 AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manuf... CGMP Deviations: Products not manufactured under current good manufacturing practices. Class II Ecometics, Inc.
Aug 2, 2023 Helix CBD Therapy Cream (Menthol 7.4%), packaged in a) 3 g pouch (NDC 30775-0... CGMP Deviations Class II Parker Laboratories, Inc.
Aug 2, 2023 Helix Tri-Active Therapy Cream (Camphor 3.2%, Menthol 7.4%, Methyl salicylate... CGMP Deviations Class II Parker Laboratories, Inc.
Aug 2, 2023 Helix Pain Relieving Cream (Menthol 7.4%), packaged in a) 5 gm pouch (NDC 307... CGMP Deviations Class II Parker Laboratories, Inc.
Aug 2, 2023 Helix CBD Clinical Cream (Menthol 7.4%), packaged in a)3 gm pouches (NDC30775... CGMP Deviations Class II Parker Laboratories, Inc.
Aug 2, 2023 Rasagiline Tablets 0.5mg, 30-count bottle, Rx only, Mylan Pharmaceuticals Inc... Failed dissolution specifications - results obtained were below spec average. Class II Aurobindo Pharma USA Inc.
Aug 2, 2023 Protex Foaming Hand Sanitizer (Benzalkonium Chloride 0.13%), packaged in a) 2... CGMP Deviations Class II Parker Laboratories, Inc.
Jul 21, 2023 Rufinamide Tablets, USP 400 mg, packaged in 120-count bottle, Rx only, Distri... cGMP deviations: Batch was released prior to approval. Class II Aurobindo Pharma USA Inc.
Jul 21, 2023 Cromolyn Sodium Oral Solution (Concentrate) 100 mg/5 mL 96 Plastic Ampules pe... CGMP deviation: product released prior to supplier approval. Class II The Ritedose Corporation
Jul 21, 2023 Rufinamide Tablets, USP 200 mg, packaged in 120-count bottle, Rx only, Distri... cGMP deviations: Batch was released prior to approval. Class II Aurobindo Pharma USA Inc.
Jul 20, 2023 FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL ... cGMP deviations: due to shipment of rejected units. Class II SCA Pharmaceuticals
Jul 17, 2023 succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc.... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL 2 mcg/mL and bupivacaine 0.0625% PF in 0.9% sodium chloride, Total V... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 morphine in 0.9% sodium chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx o... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 1000 mcg/100 mL, (10 mcg/mL), 100 mL bag, R... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 ketamine in 0.9% sodium chloride, 50 mg/5mL (10mg/mL), 5 mL syringe, Rx only... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 vecuronium, 10 mg/10mL, (1 mg/mL), 10 mL syringe, Rx only, PARALYZING AGENT, ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 PHENYLephrine in 0.9 sodium chloride, 400 mcg /10 mL, (40 mcg/mL), 10 mL Syri... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL 2 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride / Total V... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syring... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 PHENYLephrine in 0.9 sodium chloride, 800 mcg /10 mL, (80 mcg/mL), 10 mL Syri... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 PHENYLephrine in 0.9% sodium chloride, 1000 mcg/10 mL, (100 mcg/mL), 10 mL sy... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone added to 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 100 mL... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 morphine in 0.9% sodium chloride, 125 mg/25 mL, (5 mg/mL), 30 mL Syringe, Rx ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 morphine in 0.9% Sodium Chloride, 50 mg/50 mL (1mg/mL), 50 mL Syringe, Rx onl... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 5000 mcg/250 mL, (20 mcg/mL), 250 mL Bag, R... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 2500 mcg/250 mL, (10 mcg/mL), 250 mL bag, R... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 midazolam in dextrose 5%, 50 mg /50 mL, (1 mg/mL), 50 mL Syringe, Rx only, Ce... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL 1.5 mcg/mL and bupivacaine 0.125% PF in 0.9% sodium chloride, Total ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL, 1250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixt... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL in 0.9% sodium chloride, 10 mcg/1 mL, (10 mcg/mL), 3 mL Syringe, Rx ... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syring... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 lidocaine 2%, 100 mg /5 mL, (20 mg/mL), 5 mL Syringe, Rx only, CAPS, Inc., 79... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services Inc
Jul 17, 2023 fentaNYL, 5000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixtur... Lack of assurance of sterility: Lack of validation data for sanitization cycles Class II Central Admixture Pharmacy Services 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.