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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

14,380 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 27, 2017 HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 HYDROmorphone HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Atropine Sulfate Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Midazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ketamine HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Esmolol HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Neostigmine Methylsulfate Injection in all strengths, all doses, and all pack... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Lidocaine HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all dos... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all p... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Methadone HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Midazolam HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Nicardipine HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ropivacaine HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 22, 2017 Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Cam... Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled ... Class II Hetero Labs Limited Unit V
Dec 20, 2017 Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxyben... Failed Stability Specifications:stability failure at 12 months, long term RT conditions. Class II Odan Laboratories Ltd
Dec 20, 2017 DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged... Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag. Class II Fresenius Medical Care Renal Therapies Group, LLC
Dec 20, 2017 Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. ... Failed Stability Specifications:stability failure at 12 months, long term RT conditions. Class II Odan Laboratories Ltd
Dec 19, 2017 Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX O... Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalpro... Class II Unichem Pharmaceuticals Usa Inc
Dec 15, 2017 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), ... Presence of Particulate Matter: identified as polyethylene, which is consistent with the material... Class II B. Braun Medical Inc
Dec 15, 2017 Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distribut... Presence of particulate matter Class II Amneal Pharmaceuticals
Dec 14, 2017 Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (... GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. Class II SHISEIDO AMERICA INC.
Dec 14, 2017 Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate... GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. Class II SHISEIDO AMERICA INC.
Dec 14, 2017 Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octoc... GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. Class II SHISEIDO AMERICA INC.
Dec 14, 2017 Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, ... GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. Class II SHISEIDO AMERICA INC.
Dec 14, 2017 SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90... Failed Stability Specifications Class II Boehringer Ingelheim Pharmaceuticals, Inc.
Dec 14, 2017 Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg,... Failed Impurities/Degradation Specifications: High out of specification test result for the Moexi... Class II Teva Pharmaceuticals USA
Dec 14, 2017 bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titan... GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. Class II SHISEIDO AMERICA INC.
Dec 13, 2017 INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx ... Failed Stability Specifications: Product stability testing results did not meet specifications fo... Class II ALLERGAN
Dec 12, 2017 Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 ... Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burk... Class II Woodfield Pharmaceutical, LLC
Dec 7, 2017 Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syring... Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and bey... Class II SCA Pharmaceuticals
Dec 7, 2017 Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosoli... Defective Container: products showed leakage (bubbles, foaming) of propellant and product from th... Class II Johnson & Johnson
Dec 7, 2017 Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifyin... Defective Container: products showed leakage (bubbles, foaming) of propellant and product from th... Class II Johnson & Johnson
Dec 7, 2017 Neutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%),... Defective Container: products showed leakage (bubbles, foaming) of propellant and product from th... Class II Johnson & Johnson
Dec 4, 2017 Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/... Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg Class II Solco Healtcare US LLC
Dec 4, 2017 Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, ... Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did ... Class II ALLERGAN
Nov 30, 2017 All sterile drug preparations remaining within expiry prepared from Fentanyl ... Lack of sterility assurance. Class II Intrathecal Compounding Specialist, LLC
Nov 30, 2017 All sterile drug preparations remaining within expiry prepared from Sufentani... Lack of sterility assurance. Class II Intrathecal Compounding Specialist, LLC
Nov 30, 2017 All sterile drug preparations remaining within expiry prepared from Hydromorp... Lack of sterility assurance. Class II Intrathecal Compounding Specialist, LLC
Nov 30, 2017 All sterile drug preparations remaining within expiry prepared from Morphine ... Lack of sterility assurance. Class II Intrathecal Compounding Specialist, LLC
Nov 29, 2017 Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Z... Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets... Class II Prinston Pharmaceutical Inc
Nov 28, 2017 Vertra Elemental Resistance (Octyl Methoxycinnamate 6%, Oxybenzone 5%, Titani... CGMP Deviations: products manufactured in a manner that may impact product quality that includes ... Class II EAI-JR286 INC
Nov 20, 2017 Paroxetine Tablets USP, 30 mg, a) 30 count (NDC 68382-099-06), b) 500 count... Presence of Foreign Tablets/Capsules: Risperidone Tablets were found in bottle of Paroxetine Tablets Class II Zydus Pharmaceuticals USA Inc
Nov 20, 2017 Amethyst (Levonorgestrel and Ethinyl Estradiol Tablets USP, 90mcg/20mcg), 28... Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil a... Class II Teva Pharmaceuticals USA
Nov 20, 2017 Glenmark Mometasone Furoate Cream, USP, 0.1%, 45 g Rx Only Manufactured by: G... CGMP Deviations: Market complaints related to "gritty texture". Class II Glenmark Pharmaceuticals Inc., USA
Nov 17, 2017 Pravastatin Sodium USP, tablets, 40 mg, 90-count bottle, Rx only, Manufacture... Presence of foreign tablets/capsules: This product lot is being recalled due to a pharmacy compla... Class II Lupin Limited
Nov 16, 2017 Human Chorionic Gonadotropin 6,000 iu/Vial, For SC Use -Lyophilized, Rx Only,... Labeling: Incorrect or Missing Lot and/or Exp Date: Beyond Use Date (BUD) exceed the BUD/EXP of a... Class II KRS Global Biotechnology, 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.