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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

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
May 15, 2014 Desferal 2 gm/8 mL Sterile Water, Trinity Care Solutions, 202-C SW 17th Stree... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Unasyn (ampicillin/sulbactam) 1.5 gm/100 mL 0.9%NS, Trinity Care Solutions, 2... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Invanz (ertapenem)1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Tobramycin 300 mg/7.5 mL Syringe (for Neb), Trinity Care Solutions, 202-C SW ... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 1.25 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Stree... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefazolin 1 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Vancomycin 1 gm/100 mL 0.9%NS,Trinity Care Solutions, 202-C SW 17th Street, O... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Cefepime 2 gm/100 mL 0.9%NS, Trinity Care Solutions, 202-C SW 17th Street, Oc... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 15, 2014 Ceftriaxone 2 gm/100 mL D5W, Trinity Care Solutions, 202-C SW 17th Street, Oc... Lack of Assurance of Sterility; All lots of sterile products compounded by the pharmacy within ex... Class II Franck's Lab Inc dba Trinity Care Solutions
May 12, 2014 Polidocanol 1% Solution for Injection, each mL contains Polidocanol (Laureth ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Polidocanol 0.5% Solution for Injection, Polidocanol (Laureth 9) 5mg, 50 mL,... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Mannitol 5% Solution for injection, Mannitol 50 mg, also contains Sterile Wat... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 40 mcg, a) 5 mL... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 2 mg, Alprostadil 20 mcg, 10 mL, ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Levocarnitine Solution for injection, l-Carnitine 50 mg, Also Contains Steril... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 PYRIDOXINE HCL, Pyridoxine HCl 100mg, Also Contans: Benzyl Alcohol, Sodium Ch... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Liver Derivative Complex for injection, each mL contains: Liver Derivative Co... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 20 mcg, a) 5 mL... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, Alprostadil 10 mcg, a) 5 mL... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 LIPOTROPIC GOLD, Each mL contains: Levocarnitine 5 mg, Thiamine 50 mg, Ribofl... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 0.5 mg, Alprostadil 10 mcg, a) 5 ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Polidocanol 5% Solution for Injection, each mL contains Polidocanol (Laureth ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 B-Complex/Adenosine Inj sol, Adenosine-5-Monophosphate 0.03g, Choline Chlorid... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 METHYLCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Methylcobalamin 1... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Testosterone Cypionate for Injection, each mL contains Testosterone Cypionate... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 Papaverine HCl 30 mg, Phentolamine Mesylate 1 mg, a) 5 mL and b) 10 mL, JOHN ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 MIC PLUS B12, Adenosine, L-Carnitine, Contains: Methionine 15mg, Choline 100... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
May 12, 2014 CYANOCOBALAMIN FOR INTRAMUSCULAR OR SUBCUTANEOUS USE ONLY, Each mL contains: ... Lack of Assurance of Sterility: Lack of sterility assurance in compounded aseptically filled inje... Class II John W Hollis Inc
Apr 9, 2014 Gemcitabine For Injection USP, 1 g, (lyophilized), For Intravenous Use Only, ... Lack of Assurance of Sterility: A particle excursion for a different batch of the same product ma... Class II Caraco Pharmaceutical Laboratories, Ltd.
Mar 21, 2014 ParaGard T 380A - Intrauterine Copper Contraceptive, 176 mg of copper wire, D... Non-sterility: due to a failed sterility test Class II Teva Pharmaceuticals USA
Mar 4, 2014 Zoledronic Acid Injection 5 mg per 100 mL (0.05 mg/mL), 100 mL single-use bag... Lack of Assurance of Sterility; leaking of premix bags Class II Sagent Pharmaceuticals Inc
Feb 26, 2014 All sterile drugs compounded between 2/21/14 and 2/24/14. Lack of Assurance of Sterility: All compounded products. Class II New England Home Therapies, Inc
Feb 11, 2014 0.9% Sodium Chloride Injection, USP 1000 mL Flexible Container, Rx Only, Hosp... Lack of Assurance of Sterility:Solution leaking through the port cover of the primary container, ... Class II Hospira Inc.
Feb 11, 2014 Dianeal PD-2 Peritoneal Dialysis Solution with 1.5% Dextrose, 6000 mL Ambu-Fl... Non-Sterility: Complaints of leaks and particulate matter identified as mold in the solution bag ... Class I Baxter Healthcare Corp.
Jan 16, 2014 ROHTO Cooling Eye Drops, Itch Relief, Soothes Itch & Burn, relief, Astringent... Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh... Class II The Mentholatum Co.
Jan 16, 2014 ROHTO Dry Eye, hydra, Lubricant Eye Drops, Sterile, Net. Wt. 0.4 FL OZ (13 mL... Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh... Class II The Mentholatum Co.
Jan 16, 2014 ROHTO Redness Relief, arctic, Redness Reliever, Lubricant Eye Drops, Sterile,... Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh... Class II The Mentholatum Co.
Jan 16, 2014 ROHTO Redness Relief, ice, Redness Reliever, Lubricant, Astringent Eye Drops,... Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh... Class II The Mentholatum Co.
Jan 16, 2014 ROHTO Redness Relief, Cool, Redness Reliever, Lubricant Eye Drops, Sterile, N... Lack of Assurance of Sterility: The Mentholatum Company has recalled Rohto Arctic, Rohto Ice, Roh... Class II The Mentholatum Co.
Jan 9, 2014 Aminosyn 3.5% M Sulfite-Free, A Crystalline Amino Acid Solution* with Mainten... Lack of Assurance of Sterility; potential leakage from administrative port. Class II Hospira Inc.
Jan 9, 2014 Heparin Sodium 2000 USP Heparin Units per 1000 mL (2 USP Heparin Units/mL) in... Lack of Assurance of Sterility; potential leakage from administrative port. Class II Hospira Inc.
Dec 19, 2013 MINERAL IV Injection, compounded by Abrams Royal Pharmacy, Inc., Dallas, TX Non-Sterility; analytical results found product to contain Sphingomonas paucimobilis Class I Abrams Royal Pharamacy
Dec 19, 2013 All Unexpired Sterile Drug Products, compounded by Abrams Royal Pharmacy Inc.... Lack of Assurance of Sterility Class II Abrams Royal Pharamacy
Dec 12, 2013 Bupivacaine 3%, 300 mL units, Not for Dispensing, For Hospital Administration... Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... Class II Zions RX Formulations Services LLC dba RX Formu...
Dec 12, 2013 Potassium Phosphates 4.4mEq/3mM/mL Vials, Not for Dispensing, For Hospital Ad... Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... Class II Zions RX Formulations Services LLC dba RX Formu...
Dec 12, 2013 Magnesium Sulfate 10gm in 250mL Lactated Ringers Bags, Not For Dispensing, Fo... Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... Class II Zions RX Formulations Services LLC dba RX Formu...
Dec 12, 2013 Vitamin B-12 injections, a) 1 mL and b) 30 mL units, Not for Dispensing, For ... Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... Class II Zions RX Formulations Services LLC dba RX Formu...
Dec 12, 2013 Calcium Gluconate 10% for Injection, SDV 100 mL SDV, PF, Not for Dispensing, ... Non-Sterility: RX Formulation initiated this recall due to a report of microbial contamination fo... Class I Zions RX Formulations Services LLC dba RX Formu...
Dec 12, 2013 Oxytocin 30 Units in 500mL Sodium Chloride 0.9% Bags, Not for Dispensing, For... Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... Class II Zions RX Formulations Services LLC dba RX Formu...
Dec 12, 2013 Sodium Bicarbonate 8.4%, a) 10 mL, b) 20 mL, and c) 22 mL units, Not for Disp... Lack of Assurance of Sterility: The firm expanded the recall to other injectable products due to ... Class II Zions RX Formulations Services LLC dba RX Formu...

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.