Vehicle Safety
Recalls Search 320,000+ NHTSA safety recalls Complaints 2.1M+ consumer safety complaints TSBs 4.7M technical service bulletins VIN Lookup Decode any vehicle VIN instantly OBD Codes 12,000+ diagnostic trouble codes Fuel Economy EPA MPG data for all vehicles Safety Ratings 11,700+ NHTSA crash test ratings Investigations 5,300+ NHTSA defect investigations Statistics Recall trends & safety analysis
Consumer Safety
Product Safety 9,700+ CPSC product recalls Food Safety 28,600+ FDA food recalls Pet Safety 1.3M FDA animal adverse events Drug Safety 17,500+ FDA drug recalls Device Safety 38,400+ FDA device recalls Workplace Safety 102,900+ OSHA injury reports Brand History Cross-category recall lookup by company
Infrastructure
Bridge Safety 624,000 bridge inspections Aviation Safety 30,000+ NTSB aviation events Dam Safety 92,600 dam safety records Water Safety 433,000+ public water systems Railroad Safety 438,000+ rail crossings Pipeline Safety 8,800+ pipeline incidents State Safety Dashboards Safety grades for all 50 U.S. states ZIP Safety Report Check any 5-digit ZIP across 9 datasets
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases
Blog

Vehicle Safety

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

Infrastructure

Bridge Safety624,000 bridge inspections Aviation Safety30,000+ NTSB aviation events Dam Safety92,600 dam safety records Water Safety433,000+ public water systems Railroad Safety438,000+ rail crossings Pipeline Safety8,800+ pipeline incidents State DashboardsSafety grades for all 50 states ZIP ReportAny 5-digit ZIP across 9 datasets

Public Health

Nursing Homes14,700 CMS rated facilities Environmental80,000+ hazardous sites & releases BlogGuides, news & safety insights

Browse Drug Recalls

1,749 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,749 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 1,749 FDA drug recalls, Class I.

Clear
DateProductReasonClassFirm
Nov 3, 2014 Forever Beautiful INFINITY, capsules, 300mg in 60-count bottles, 900 Commonwe... Marketed Without an Approved NDA/ANDA: FDA analysis found product to contain sibutramine and phen... Class I REFA Enterprises, LLC
Oct 16, 2014 1% LIDOCAINE HCl Injection, USP, 10 mg/mL, 30 mL Single-dose, Preservative-Fr... Presence of particulate matter: A returned customer sample was evaluated and found to have human ... Class I Hospira Inc.
Oct 6, 2014 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), 20 mL Single patie... Temperature Abuse: Products experienced uncontrolled temperature excursions during transit. Class I Hospira Inc.
Sep 11, 2014 HEPARIN SODIUM, 1000 USP Heparin Units/500 mL (2 USP Heparin Units/mL), in 0.... Presence of Particulate Matter: A particulate, confirmed as human hair, was found sealed between ... Class I Hospira Inc.
Sep 5, 2014 Ascorbic Acid 500 mg/mL Sterile Injection, 50mL Multi-dose Vial, Rx only, Ph... Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... Class I Pharmacy Creations
Sep 5, 2014 Glutathione 100mg/mL Sterile Injection, 30 mL Multi Dose Vial, Rx only, Pharm... Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... Class I Pharmacy Creations
Sep 5, 2014 Tropi/Cyclo/Phenyl/Tobra/Flurb (1/1/10/0.3/0.03)% Sterile Ophthalmic Solution... Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... Class I Pharmacy Creations
Sep 5, 2014 Magnesium Chloride 20% (200mg/mL) Sterile Injection, 50mL Multi-Dose Vial, Rx... Non-Sterility: Failing sterility results were obtained from the recalling firm's contract testing... Class I Pharmacy Creations
Aug 8, 2014 CUBICIN (daptomycin for injection) 500 mg, For Intravenous Use Only, Rx Only,... Presence of Particulate Matter: Foreign particulate matter (tiny black specs) were observed at th... Class I Cubist Pharmaceuticals, Inc.
Aug 7, 2014 Dianeal Low Calcium (2.5 mEq/L) Peritoneal Dialysis Solution with 2.5% Dextro... Presence of Particulate Matter: particulate matter was found during the manufacturing process. Class I Baxter Healthcare Corp.
Aug 1, 2014 CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufact... Presence of Particulate Matter: Potential presence of glass particulate matter in the vials. Class I Cubist Pharmaceuticals, Inc.
Jul 29, 2014 Lidocaine HCl Injection, USP, 2%, 20 mg per mL, Preservative-Free, 5 mL Singl... Presence of Particulate Matter: The product was discolored and contained visible particulates (ir... Class I Hospira Inc.
Jul 24, 2014 Epel 18 mg Estradiol Pellet, For In Office Use Only, For In Office Administra... Non-Sterility: The recalled lot failed sterility testing. Class I Physician Preferred Medical, LLC
Jul 18, 2014 N-Acetyl Cysteine 20% 4 mL Vial Stock Code: 4133 Non-Sterility: One lot of N-Acetyl Cysteine vials tested positive for Herbaspirillum huttiense. Class I Unique Pharmaceutical, Ltd
Jul 11, 2014 0.9% Sodium Chloride Injection USP MINI-BAG Plus Container, 100 mL VIAFLEX Si... Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. Class I Baxter Healthcare Corp.
Jul 11, 2014 Potassium Chloride Injection, 20 mEq per 50 mL, 50 mL Sterile Single Dose Con... Presence of Particulate Matter: particulate matter identified as fibers and/or plastics Class I Baxter Healthcare Corp.
Jul 11, 2014 0.9% Sodium Chloride Injection USP, packaged in a) 50 mL VIAFLEX Container ba... Presence of Particulate Matter: particulate matter identified as fibers and/or plastics. Class I Baxter Healthcare Corp.
Jul 10, 2014 LACTATED RINGER'S and 5% DEXTROSE Injection USP, 1000 mL, flexible containers... Non-Sterility: Confirmed customer complaint of particulate matter floating within the solution of... Class I Hospira Inc.
Jul 1, 2014 Ibuprofen Tablets, USP, 600 mg, 100 tablets per carton (10 x 10), Rx Only, Pa... Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... Class I American Health Packaging
Jul 1, 2014 Oxcarbazepine Tablets, 300 mg, 100 tablets per carton (10 x 10), Rx Only, Pac... Labeling: Label Mix-Up: Some cartons of AHP Ibuprofen Tablets, USP, 600mg, lot #142588 that conta... Class I American Health Packaging
Jun 25, 2014 Ascorbic Acid 500 mg/mL Sterile Injection, 50 mL Multi-dose Vial, Rx only, Ph... Non-Sterility: Pharmacy Creations is recalling Ascorbic Acid 500 mg/mL 50 mL vials due to mold co... Class I Pharmacy Creations
Jun 17, 2014 Marcaine (bupivacaine HCl) injection, USP, 0.5%, Preservative-Free, 30 mL (15... Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible ... Class I Hospira Inc.
Jun 2, 2014 Soliris (eculizumab), 300 mg/30 mL (10 mg/mL), 30 mL Single-Use Vial, Rx only... Presence of Particulate Matter: Product failed the appearance for the presence of visible particl... Class I Alexion Pharmaceuticals, Inc.
May 28, 2014 del Nido Cardioplegia with Lidocaine 1052.8 ml, Rx Only, Central Admixture Ph... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
May 28, 2014 adenosine 90 mg in 0.9% sodium chloride/90 mL, Rx Only, Central Admixture Pha... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
May 28, 2014 PEDIATRIC CARDIOPLEGIA, 255 mL, Rx Only, Central Admixture Pharmacy Services,... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
May 28, 2014 LOW Potassium Cardioplegia 792 mL, Rx Only, Central Admixture Pharmacy Servic... Non Sterility; microbial contamination identified as Aspergillus species Class I Central Admixture Pharmacy Services, Inc.
May 12, 2014 COUMADIN FOR INJECTION (Warfarin Sodium for Injection, USP 5 mg Single-Use Vi... Presence of Particulate Matter: particulate matter identified as metallic-like and non-metallic c... Class I Bristol-Meyers Squibb
May 12, 2014 0.9 % Sodium Chloride Injection, USP, 1000 mL in VIAFLEX Plastic Container, B... Presence of Particulate Matter; blue polyisoprene shavings found inside the bag port tubes Class I Baxter Healthcare Corp.
May 5, 2014 AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongwei ... Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain und... Class I Eugene Oregon, Inc.
May 5, 2014 MOJO RISEN, 650 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Spr... Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain und... Class I Eugene Oregon, Inc.
May 5, 2014 Black Ant, 2800 mg, four capsules per box, Manufacturer Qinghai Baojiantang P... Marketed Without an Approved NDA/ANDA: Eugene FDA laboratory analyses determined they contain und... Class I Eugene Oregon, Inc.
Apr 30, 2014 Lite Fit USA, For Men & Women, Extreme Fat Burner, Suppresses Appetite, Boost... Marketed Without an Approved NDA/ANDA: Bacai, Inc. DBA Ky Duyen House is voluntarily recalling Li... Class I Bacai Inc. Dba Ky Duyen House
Apr 21, 2014 Marcaine (bupivacaine HCl) injection, USP, 0.25%, Preservative-Free, 10 mL (2... Presence of Particulate Matter: Confirmed customer complaint of discolored solution with visible ... Class I Hospira Inc.
Apr 21, 2014 Midazolam HCl 2 mg/ml in 0.9% Sodium Chloride in 30 mL PVC Vial, Rx Only. Ph... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I Pharmakon Pharmaceuticals
Apr 21, 2014 Midazolam HCl 1 mg/ml in 0.9% Sodium Chloride in 50 mL and 100 mL IV bag, Rx ... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I Pharmakon Pharmaceuticals
Apr 21, 2014 Atropine Sulfate 0.4 mg/ml Injection, USP, Total Dosage 0.8 mg per 2 mL, 3 mL... Incorrect/ Undeclared Excipient: Contains undeclared benzyl alcohol. Class I Pharmakon Pharmaceuticals
Apr 18, 2014 1% LIDOCAINE HCl Injection, USP, Preservative-Free, 10 mg/mL, 30 mL Single-do... Presence of Particulate Matter: Confirmed customer complaint that orange and black particulates, ... Class I Hospira Inc.
Apr 17, 2014 CUBICIN (daptomycin for injection), 500 mg single-use vial, Rx only, Manufact... Presence of Particulate Matter: Customer complaint stating that one vial contained a glass shard. Class I Cubist Pharmaceuticals, Inc.
Apr 15, 2014 Super ARTHGOLD 500mg, 120 Capsule Bottle, Dietary Supplement. Manufactured f... Marketed Without an Approved NDA/ANDA; Product contains undeclared indomethacin, diclofenac, and ... Class I Sung Soo Kim
Apr 9, 2014 THINOGENICS, WEIGHT LOSS MADE EASY! DIETARY SUPPLEMENT, 30 CAPSULES, 30 Coun... Marketed Without an Approved NDA/ANDA: Product contains undeclared sibutramine. Class I Nature's Universe
Apr 2, 2014 Propofol Injectable Emulsion, 1%, 200 mg/20 mL (10 mg/mL), For I.V. Administr... Presence of Particulate Matter: A glass defect was found on the interior neck of the vial during ... Class I Hospira Inc.
Mar 28, 2014 AFRICAN BLACK ANT, 2800 mg, 6 capsules per box, produced by: Qinghan Hongw... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 Black Ant, 4600 mg, four capsules per box, , Manufacturer Timpo Bioengineerin... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 Xzone 1200, 750 mg, one capsule per blister pack, Distributed by: Xzone, Orl... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 XZEN PLATINUM, 750 mg, 1 capsule per blister pack, Distributed by: XZEN, City... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 XZONE GOLD, 750 mg, one capsule blister pack, Distributed by: XZONE, Orland... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 XZEN GOLD,750 mg, six capsules per bottle, Distributed by: XZEN, City of Los ... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 Xzen 1200, 750 mg, six capsules per bottle, Distributed by: xzen, City of Los... Marketed Without an Approved NDA/ANDA: Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, Inc.
Mar 28, 2014 MOJO RISEN ,670 mg, 2 capsule per pouch, Distributed by: Mojo Risen, LLC, Sp... Marketed Without an Approved NDA/ANDA; Nova Products, Inc. of Aston, Pennsylvania is voluntarily ... Class I Nova Products, 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.