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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
Jun 10, 2022 Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmac... Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection Class II Wedgewood Village Pharmacy, LLC
Jun 9, 2022 Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) pe... Defective Delivery System: Out of specification for release liner removal force results at the 3... Class II Mayne Pharma Inc
Jun 7, 2022 CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL),... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cu... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 c... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg p... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cup... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per ... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cup... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 1... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg M... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 ... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dext... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 ... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 c... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 6, 2022 Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed a... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II PD-Rx Pharmaceuticals, Inc.
Jun 6, 2022 Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed a... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II PD-Rx Pharmaceuticals, Inc.
Jun 6, 2022 Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II PD-Rx Pharmaceuticals, Inc.
Jun 3, 2022 Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose via... CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 3, 2022 Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per c... CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rej... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 3, 2022 Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, ... Failed Tablet/Capsule Specification; oversized tablet found in a bottle Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 24, 2022 Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formu... Lack of Assurance of Sterility Class II US Specialty Formulations LLC
May 24, 2022 Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 ... Microbial contamination of non-sterile product. Class II Grato Holdings, Inc.
May 24, 2022 B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HC... Lack of Assurance of Sterility Class II US Specialty Formulations LLC
May 24, 2022 Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bo... Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labe... Class II Walmart Inc
May 24, 2022 Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottl... Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labe... Class II Walmart Inc
May 24, 2022 Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE A... Microbial contamination of non-sterile product. Class II Grato Holdings, Inc.
May 24, 2022 Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CV... Microbial contamination of non-sterile product. Class II Grato Holdings, Inc.
May 18, 2022 Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 EPINEPHrine Injection, USP, 0.1 mg/10 mL (10 mcg/mL), 10 mL Pre-Filled Syring... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), Preservative Free, 4 mL P... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Ketamine Hydrochloride Injection, USP, 30 mg/3 mL (10 mg/mL), 3 mL Pre-Filled... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 8.4% Sodium Bicarbonate Injection, USP, 1 mEq/mL, 4.2 g/50 mL (84 mg/mL), 1 x... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Calcium Gluconate Injection, USP 10%, 0.465 mEq Ca++/mL, 1 g/10 mL (100 mg/mL... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Losartan Potassium Tablets, USP, 50 mg, Rx Only, Manufactured by: Vivimed Lif... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Strides Pharma Inc.
May 18, 2022 Lidocaine HCl Injection, USP, 2%, 100 mg/5 mL (20 mg/mL), Preservative Free, ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Ketamine Hydrochloride Injection, USP, 50 mg/5 mL (10 mg/mL), 5 mL Pre-Filled... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Epinephrine Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Hydromorphone HCl Injection, USP, 6 mg/30 mL (0.2 mg/mL), 30 mL Pre-Filled Sy... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Glycopyrrolate Injection, USP, 0.6 mg/3 mL (0.2 mg/mL), Preservative Free, 3 ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL), Preservative F... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Oxytocin 30 Units/500 mL (0.06 Units/mL) in 0.9% Sodium Chloride Injection, U... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Losartan Potassium Tablets, USP, 100 mg, Rx Only, Manufactured by: Vivimed Li... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Strides Pharma Inc.
May 18, 2022 Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled S... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC
May 18, 2022 Succinylcholine Chloride Injection, USP, 100 mg/5 mL (20 mg/mL), Preservativ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center 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.