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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 29, 2013 Taurine 100 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Lowlite Investments, Inc. D/B/A Olympia Pharmacy
May 29, 2013 Polidocanol (0.75%, 1%, 3%, and 10%) Injection, compounded by Olympia Pharmac... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Lowlite Investments, Inc. D/B/A Olympia Pharmacy
May 29, 2013 Amikacin Sulfate 250 mg/ml Injection, compounded by Olympia Pharmacy, Orlando... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Lowlite Investments, Inc. D/B/A Olympia Pharmacy
May 29, 2013 Ketoprofen Solution 10% Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Lowlite Investments, Inc. D/B/A Olympia Pharmacy
May 29, 2013 Atipamezole 10 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Lowlite Investments, Inc. D/B/A Olympia Pharmacy
May 29, 2013 Lisinopril 20 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Lowlite Investments, Inc. D/B/A Olympia Pharmacy
May 29, 2013 MICC (Methionine, Inositol, Choline, Cyanocobalamin, Chromium) Inj and MICC 2... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Lowlite Investments, Inc. D/B/A Olympia Pharmacy
May 29, 2013 Vitamin B-Buildup Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Lowlite Investments, Inc. D/B/A Olympia Pharmacy
May 29, 2013 Voriconazole 5% Ophthalmic drop compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Lowlite Investments, Inc. D/B/A Olympia Pharmacy
May 29, 2013 Buprenorphine 0.3 mg/ml Injection, compounded by Olympia Pharmacy, Orlando, FL Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II Lowlite Investments, Inc. D/B/A Olympia Pharmacy
May 28, 2013 Wydase 5ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, ... Lack of Assurance of Sterility Class II Main Street Family Pharmacy, LLC
May 27, 2013 Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, P... Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under st... Class II Earthlabs, Inc. DBA Wise Woman Herbals
May 21, 2013 Sodium Chloride Injection, USP, a) Product code 2B1301- 50 mL in Viaflex Cont... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 21, 2013 5% Dextrose Injection, USP, in VIAFLEX Plastic Container Multi Pack, Rx Only,... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 21, 2013 Metronidazole Injection USP, RTU, 500 mg/100mL in Viaflex Plus Container, Bax... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 21, 2013 0.9% Sodium Chloride Injection, USP, in MINI-BAG Plus Container, a) 50 mL (ND... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 21, 2013 Heparin Sodium and 0.9% Sodium Chloride Injection, a) Product code 2B0944, 20... Lack of Assurance of Sterility: Specific lot numbers of these products have been identified for p... Class II Baxter Healthcare Corp.
May 16, 2013 Diazepam Injection, USP 5 mg/mL, 10 mL, Multiple-dose fliptop vial, RX only, ... Lack of Assurance of Sterility: Loose crimp applied to the fliptop vial. Class II Hospira Inc.
May 15, 2013 Proplete 34 - 39 KG (Intradialytic Parenteral Nutrition composed of amino aci... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Baxter LL bag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dialys... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Baxter Ultrabag 1.5% Amino Acids (Intraperitoneal Parenteral Nutrition - dial... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Baxter LL bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysat... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Proplete 80+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution wi... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Baxter LL bag 1% Amino Acids w/KCL (Intraperitoneal Parenteral Nutrition - di... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Fresenius bag 1% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysat... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Proplete 90+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution wi... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Baxter LL bag 2% Amino Acids (Intraperitoneal Parenteral Nutrition - dialysat... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Proplete 45 - 51 KG (Intraperitoneal Parenteral Nutrition - dialysate solutio... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Proplete 70+ KG (Intraperitoneal Parenteral Nutrition - dialysate solution wi... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Proplete 52 - 59 KG (Intradialytic Parenteral Nutrition - dialysate solution ... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 IDPN (Intradialytic Parenteral Nutrition - dialysate solution with added amin... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Proplete 60 - 69 KG (Intradialytic Parenteral Nutrition - dialysate solution ... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 15, 2013 Proplete 40 - 44 KG (Intradialytic Parenteral Nutrition - dialysate solution ... Lack of Assurance of Sterility: Sterility could not be assured for compounded sterile renal nutri... Class II Pentec Health
May 13, 2013 Trace Mineral-5 MDV, supplied in 10 mL vials, Each ML contains: 1 mg Zinc (as... Non-Sterility; contract laboratory identified Staphylococcus warneri in the product Class I Abrams Royal Pharmacy
May 2, 2013 Morphine Sulfate 25 mg/mL Injectable, 40 mL vial, compounded by The Compoundi... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Sodium EDTA 150 mg/mL Injectable, 250 mL vial, compounded by The Compounding ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 B-Complex 100 mg/mL Injectable, 50 mL vials, compounded by The Compounding Sh... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Phosphatidyl Choline 10%, Injectable, 500 mL vial, compounded by The Compound... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Baclofen 500 mcg/mL Injectable, 22 mL vial, Compounded by The Compounding Sho... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Avastin 1.25 mg/0.05 mL Injectable, 4 mL vials, Compounded by The Compounding... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Mitomycin 0.3 mg/mL Injectable, 10 mL vials, compounded by The Compounding Sh... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Glutathione 200 mg/mL Injectable, 50 mL vials, compounded by The Compounding ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Baclofen/Bupivacaine 2,000 mcg/20 mg/mL Injectable, 45 mL vial, Compounded by... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Ascorbic Acid 500 mg/mL Injectable, 100 mL and 500 mL vials, compounded by Th... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Dexpanthenol 200 mg/mL Injectable, 100 mL vial, compounded by The Compounding... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Methylcobalamin 1,000 mcg/mL Injectable, 50 mL vials, compounded by The Compo... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Baclofen 1,000 mcg/mL Injectable, 20 mL and 40 mL vial, Compounded by The Com... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Praziquantel 56.8 mg, 50 mL vial, compounded by The Compounding Shop, St. Pet... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Lipoic Acid 25 mg/mL Injectable, 100 mL vials, compounded by The Compounding ... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, INC.
May 2, 2013 Betamethasone 6 mg/mL Injectable, 5 mL vial, compounded by The Compounding Sh... Lack of Assurance of Sterility: FDA inspection findings resulted in concerns regarding quality co... Class II THE COMPOUNDING SHOP, 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.