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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

6,306 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,306 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 6,306 FDA drug recalls.

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DateProductReasonClassFirm
Aug 13, 2021 LEVOCARNITINE 100MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 GLUTATHIONE 200MG/ML MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 CALCIUM GLUCONATE 10% INJ (PF), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 PROGESTERONE 100MG/ML MDV OIL INJECTION, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 MIC 25/50/50MG/ML MDV, Rx only,Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 TEST CYP 200MG/ML IN SESAME OIL MDV, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 METHYLCOBALAMIN 1000MCG/ML MDV INJ, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ACETYLCYSTEINE 10% OPTH SOLN, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 VIT B COMPLEX INJ SOLN (HP), Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ASCORBIC ACID (NON-CORN) 500MG/ML MDV SOLN, Rx only, Red Mountain Compounding Rx Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 13, 2021 ASCORBIC ACID (NON-CORN) 500MG/ML SOLN (PF), Rx only, Red Mountain Compoundin... Lack of Assurance of Sterility: FDA inspection raised sterility assurance concerns Class II First Royal Care Co. LLC, dba Red Mountain Comp...
Aug 12, 2021 Pi yen chin Ophthalmic Redness Reliever Drops Made in China, Net Wt.: 10 ml (... Labeling: Not Elsewhere Classified; The packaging states these are ophthalmic drops. However, the... Class II ANHUI WELCOME FOREIGN TRADE CO.,LTD.
Aug 10, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... Non-Sterility: firm's third party lab confirmed microbial contamination. Class I SterRx, LLC
Aug 10, 2021 Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... Lack of Assurance of Sterility Class II SterRx, LLC
Aug 2, 2021 Artificial Tears Ointment, Lubricant Eye Ointment, Net Wt. 3.5 g (1/8 oz.) pe... Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stabil... Class II Akorn, Inc.
Jul 30, 2021 Succinylcholine Chloride 100 mg/5 mL (20 mg/mL), 5 mL Syringes, Rx only, For ... Lack of sterility assurance Class II BayCare Integrated Service Center, LLC /dba Bay...
Jul 30, 2021 FLUDARABINE PHOSPHATE FOR INJECTION, USP, 50 mg per vial, Single dose vial, R... Lack of Assurance of Sterility: the manufacturing firm had microbial recoveries during environmen... Class II Custopharm, Inc.
Jul 29, 2021 Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, packaged in a... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Epoprostenol Sodium for Injection, 1.5 mg/vial, 10 mL vials, Rx only, Teva Ph... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Methylprednisolone Acetate Injectable Suspension USP, 80 mg/mL, packaged in a... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Idarubicin Hydrochloride Injection 20 mg/20 mL, 20 mL single-dose vial, Rx on... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Octreotide Acetate Injection 100 mcg/mL, 1 mL single-dose vial, Rx only, Teva... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Adenosine Injection, USP, 60mg/20mL (3 mg/mL), 20 mL single-dose vial, Rx onl... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Vecuronium Bromide for Injection 10 mg, 10mL vial, Rx only, Teva Pharmaceutic... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Octreotide Acetate Injection 50 mcg/mL, 1 mL single-dose vial, Rx only, Teva ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Metoclopramide Injection USP, 10 mg/2mL (5 mg/mL) 2 mL single-use vial, Rx on... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx on... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Alprostadil Injection USP, 500 mg/mL, 1 mL single dose, vials, 5 mL single us... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Octreotide Acetate Injection 1000 mcg/5mL, 5 mL multi-dose vial, Rx only, Tev... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 DAUNOrubicin Hydrochloride Injection 20 mg/4mL, 4mL Single Dose vials, 10 in ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Haloperidol Decanoate Injection 100 mg/mL, packaged in a) 1 mL single-dose vi... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Amikacin Sulfate Injection USP 1 gram/4mL (250mg/ML), 4 mL single-dose vials,... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 29, 2021 Norepinephrine Bitartrate Injection, USP 4 mg/4 mL, 4 mL single dose vials, p... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Jul 9, 2021 Compounded Lyophilized Semorelin/Ipamorelin 3 mg For subcutaneous or intramus... Lack of Assurance of Sterility Class II Innoveix Pharmaceuticals Inc
Jul 9, 2021 Compounded Lyophilized AOD-9604, 3 mg For subcutaneous or intramuscular injec... Lack of Assurance of Sterility Class II Innoveix Pharmaceuticals Inc
May 11, 2021 C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Comp... Non-Sterility Class I People's Custom Rx and Clinical Care, LLC
Apr 26, 2021 Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multipl... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx ... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Onl... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 26, 2021 Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx On... Lack of Assurance of Sterility Class II Teva Pharmaceuticals USA
Apr 12, 2021 Betadine (Povidone-Iodine) 5%, 0.5mL per syringe Single Use Syringe Rx only, ... Defective container; syringe content migrating past the seal of the plunger may cause a lack of a... Class II Edge Pharma, LLC
Mar 19, 2021 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Lack of Assurance of Sterility: Product is being recalled because at labeled storage conditions ... Class II CareFusion 213, LLC
Mar 19, 2021 BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relativ... Class I CareFusion 213, LLC
Mar 19, 2021 BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v... Non-sterility.Product is being recalled because at labeled storage conditions of 30*C/75% Relativ... Class I CareFusion 213, 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.