Skip to main content
Get Alerts

FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

Filters
Recall details
Location
Date range
Clear filters

Showing 5,501–5,520 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solution, 50 mL glass vial, Rx only, Manufactured by Massachusetts General Hospital PET Center, Boston, MA NDC 76318-334-50

by The General Hospital Corporation

Reason
Lack of Assurance of Sterility
Recall initiated
February 17, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed to one direct account.

View recall →

Drug Recall Terminated Historical recordClass II

Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 30-count (3 x 10 unit-dose) tablets per carton (NDC 43598-344-31); Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540; Made in India.

by Dr. Reddy's Laboratories, Inc.

Reason
Failed Dissolution Specifications
Recall initiated
February 17, 2021
Reported by FDA
March 3, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0051-01), packaged in 25X1ML vials per tray (NDC 0703-0051-04), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1995-01.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL, 10 mL Vial (NDC 0703-2914-01), packaged in 10 x 10 mL Vials per tray (NDC 0703-2914-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-dose Vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-5657-01.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC 0703-4502-01), packaged in 25 x 2 mL Single-Use Vials per tray (NDC 0703-4502-04), Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single-Dose Vial (NDC 0703-0031-01), packaged in 25X1ML per tray (NDC 0703-0031-04), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0703-1985-01.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9258-01), packaged in 2X50ML per tray (NDC 0703-9258-09), Rx only, TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5051-01), packaged in 10X1 mL Vials per Tray (NDC 0703-5051-03), Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), packaged in 10X20 ML Single Use Vials per tray (NDC 0703-5075-03); Rx only, TEVA Pharmaceuticals USA, INC., North Wales, PA 19454.

by Teva Pharmaceuticals USA

Reason
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Recall initiated
February 10, 2021
Reported by FDA
March 3, 2021
Distribution
Product was distributed nationwide in the USA and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass I

BD ChloraPrep Hi-Lite Orange 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA), Sterile Solution, 0.01 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion El Paso, TX 79912, subsidiary of Becton, Dickinson and Co., NDC 54365-400-33 REF 930415

by CareFusion 213, LLC

Reason
Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Recall initiated
July 7, 2020
Reported by FDA
March 3, 2021
Distribution
Distributed in Puerto Rico and Oman

View recall →

Drug Recall Terminated Historical recordClass I

ChloraPrep With Tint 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Non-Sterile Solution - Hi-Lite Orange, 0.10 fl. oz. (3 ml) each, 25 applicators in carton, CareFusion El Paso, TX 79912, NDC 054365-400-11 Cat. No. 260415

by CareFusion 213, LLC

Reason
Microbial Contamination of Non-Sterile Products:Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Recall initiated
July 7, 2020
Reported by FDA
March 3, 2021
Distribution
Distributed in Puerto Rico and Oman

View recall →

Drug Recall Terminated Historical recordClass I

BD ChloraPrep Clear, 2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopropyl alcohol (IPA) Sterile Solution, 0.10 fl. oz. (3 ml) each, 25 Applicators in carton, CareFusion 213, LLC, El Paso, TX 79912, subsidiary of Becton, Dickinson and Co, NDC 54365-400-32 REF 930400

by CareFusion 213, LLC

Reason
Non-sterility: Product is being recalled to climatic Zone IV regions of the world where at the labeled storage conditions of 30*C/75% Relative Humidity for more than 6 months, there is the potential for growth of Aspergillus penicillioides, a type of fungus, resulting in a breach of the package integrity.
Recall initiated
July 7, 2020
Reported by FDA
March 3, 2021
Distribution
Distributed in Puerto Rico and Oman

View recall →

Drug Recall Terminated Historical recordClass II

Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68

by Ascend Laboratories LLC

Reason
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Recall initiated
January 22, 2021
Reported by FDA
February 24, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only, Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88

by Ascend Laboratories LLC

Reason
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Recall initiated
January 22, 2021
Reported by FDA
February 24, 2021
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Auryxia (ferric citrate) tablets, 210 mg*, 200 tablets bottle, RX ONLY, Manufactured for and distributed by: KERYX BIOPHARMACEUTICALS, INC., 245 First Street, Suite 1400, Cambridge, MA 02142, USA, NDC 59922-0631-01.

by Akebia Therapeutics dba Keryx Biopharmaceutials, Inc

Reason
Failed Dissolution Specifications
Recall initiated
January 29, 2021
Reported by FDA
February 24, 2021
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-133-01

by Wilshire Pharmaceuticals Inc

Reason
Failed Dissolution Specifications
Recall initiated
February 4, 2021
Reported by FDA
February 24, 2021
Distribution
FL, TX

View recall →

Drug Recall Terminated Historical recordClass II

Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wilshire Pharmaceuticals, Inc., Atlanta, GA 30328, Product of India, NDC 52536-129-01

by Wilshire Pharmaceuticals Inc

Reason
Failed Dissolution Specifications
Recall initiated
February 4, 2021
Reported by FDA
February 24, 2021
Distribution
FL, TX

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.