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 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
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
Public Health
Nursing Homes 14,700 CMS rated facilities Environmental 80,000+ hazardous sites & releases

Browse Drug Recalls

1,788 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,788 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 1,788 FDA drug recalls in 2019.

Clear
DateProductReasonClassFirm
Sep 12, 2019 Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 2.5% (25 mg/mL) / Tropic... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Fluorescein (PF) Lyophilized-For IV Use, Single Dose Vial, 500 mg/vial, Rx On... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Methionine 750 mg / Inositol 1,500 mg / Choline Chloride 1,500 mg / Pyridoxin... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Polidocanol 5%, 500 mg / 10 mL (50 mg/mL), 10 mL Vial for IV Use, Rx Only, KR... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 PHENYephrine HCl in 0.9% Sodium Chloride (PF) (Contains Sulfites), 100 mg / 2... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Hydroxocobalamin 10 mL Vial 5 mg/10 mL (0.5 mg/mL) For IM Use, Rx Only, KRS G... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 LIDOcaine HCl 0.75%(7.5 mg/mL)/ EPINRPHrine 0.025% (0.25 mg/mL) (PF) (Sulfite... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Labetalol HCl 5 mg/mL 20 mg/4 mL (5 mg/mL) 4 mL Fill in a 6 mL Single Dose Sy... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made... Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco... Class III Pfizer Inc.
Sep 12, 2019 Sermorelin Acetate 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS Global B... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Bacteriostatic Water for Injection, 30 mL Vial, Rx Only, KRS Global Biotechno... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sodium Bicarbonate 8.4%, 4,200 mg / 50 mL 50 mEq / 50 mL (84 mg/mL) (1 mEq/mL... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sodium Citrate 40 mg/mL (4%) / Gentamicin 0.32 mg/mL. 30 mL vial for Intra-Ca... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 NORepinephrine in 0.9% Sodium Chloride (PF), 250 mL IV bag, 4 mg/250 mL (0.01... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Phenylephrine HCl 1.5% (15 mg/mL) Lidocaine HCl 1% (10 mg/mL) (PF) (Sulfite F... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Isoproterenol HCL (PF) in D5W, 200 mcg / 50 mL (4 mcg/mL), 50 mL IV Bag, Sing... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Hydroxocobalamin 30 mg/30 mL (1 mg/mL) 30 mL Vial For IM Use, Rx Only, KRS Gl... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Ascorbic Acid (Tapioca Source) 25 g/50 mL (0.5 g/mL) 50 mL Vial--For SC/IM Us... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 NEOstigmine Methylsulfate (PF), 3 mg/3 mL (1 mg/mL), 3 mL Single Dose Syringe... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartr... Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... Class I Shire Human Genetic Therapies, Inc.
Sep 12, 2019 Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, ... Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... Class I Shire Human Genetic Therapies, Inc.
Sep 12, 2019 L-Carnitine 27 mL Fill in a 30 mL Vial, For Dilution Use Only, 2,025 mg/27 mL... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Cyclopentolate HCl 1% (10 mg/mL) / Phenylephrine HCl 10% (100 mg/mL) / Tropic... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Vitamin 9A/B Lyophilized, Vial For IM Use, Rx Only, KRS Global Biotechnology ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Sermorelin, 3 mg / GHRP-2, 3 mg / Vial, For SC Use-Lyophilized, Rx Only, KRS ... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 Quadmix # 19 (Prostaglandin E1-0.75 mg / Papaverine HCl-150 mg / Phentolamine... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 NEOstigmine Methylsulfate (PF), 5 mg/5 mL (1 mg/mL), 5 mL fill in a 6 mL Sing... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 12, 2019 GLYCOpyrrolate (PF) 0.6 mg/3 mL (0.2 mg/mL) in 3 mL Single Dose Syringe, Rx O... Lack of Assurance of Sterility Class II KRS Global Biotechnology, Inc
Sep 9, 2019 Oxcarbazepine Oral Suspension, USP, 300 mg/5 mL, 250 mL per bottle, Rx Only, ... Failed Impurities/Degradation Specificattion Class II West-Ward Columbus Inc
Sep 6, 2019 Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For... Temperature Abuse; Product stored and shipped outside of labeled storage requirements. Class II Cardinal Health dba Specialty Pharmaceutical Se...
Sep 6, 2019 Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g N... Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified a... Class I Darmerica, LLC
Sep 6, 2019 Anagrelide Capsules, USP, 0.5 mg, 100-count bottle, Rx only, Manufactured in... Failed Impurities/Degradation Specifications: High Out Of Specification results for impurities de... Class II Torrent Pharma Inc.
Sep 6, 2019 Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 coun... GMP Deviation: lot not intended for commercial distribution. Class III Teva Pharmaceuticals USA
Sep 6, 2019 Bacteriostatic Water for Injection, USP, 30 mL vials, Rx only, Mfd. for: Hosp... Lack of Assurance of Sterility Class II Pfizer Inc.
Sep 6, 2019 Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: ... Failed Impurities/Degradation Specifications:OOS for unknown impurity. Class III Mylan Pharmaceuticals Inc.
Sep 4, 2019 Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count... CGMP Deviation: Presence of dark brown discoloration on edges of tablets. Class II Jubilant Cadista Pharmaceuticals, Inc.
Sep 3, 2019 Clonidine HCL and Baclofen and Fentanyl Citrate in all strengths, all doses a... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 5% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in a) 5ml , b) 10ml drop... Lack of Processing Controls: Class II Compounded Solutions in Pharmacy
Sep 3, 2019 Fentanyl Citrate in all strengths, all doses and all packaging, AnazaoHealth ... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Sufentanil Citrate PF 90 mcg/mL/Clonidine HCL PF 500 mcg/mL/Bupivacaine HCL P... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Hydromorphone HCL and Clonidine HCL in all strengths, all doses and all packa... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Clonidine HCL and Baclofen in all strengths, all doses and all packaging, Ana... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Hydromorphone HCL and Bupivacaine HCL and Baclofen and Clonidine HCL in all s... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Morphine Sulfate and Fentanyl Citrate and Baclofen in all strengths, all dose... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Morphine Sulfate in all strengths, all doses and all packaging, AnazaoHealth ... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Bupivacaine HCl and Hydromorphone HCl in all strengths, all doses and all pac... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Hydromorphone HCL and Bupivacaine HCL in all strengths, all doses and all pac... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Clonidine HCL/Hydromorphone HCL in all strengths, all doses and all packaging... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 Morphine Sulfate and Bupivacaine HCL and Clonidine HCL in all strengths, all ... Lack of Processing Controls; Environmental sampling revealed 1 CFU (Colony Forming Unit) identifi... Class II Coast Quality Pharmacy, LLC dba Anazao Health
Sep 3, 2019 20% Acetyl-L-Cysteine Ophthalmic Solutions, dispensed in 3ml dropper bottle. Lack of Processing Controls: Class II Compounded Solutions in Pharmacy

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.