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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.

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Showing 12,761–12,780 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Thiamine HCl Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Zinc Sulfate (Elemental) Injection, 10mg/mL, 30 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

M.I.C Injection (Preserved), 25/50/25mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Dexpanthenol Injection, 250mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

DMAE Dimethylaminoethanol Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Pyridoxine Injection, 100 mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Piracetam Injection, 200mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Folic Acid Injection, 10mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

L-Glutathione Injection, 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

DMSO 99% Injection, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

L-Arginine Injection, 100mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Magnesium Chloride Hexahydrate Injection 200mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Hydroxocobalamin Injection (Buffered) 1mg/mL, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Calcium Gluconate (680mOsm/L) Injection 10%, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

TNPDR Injection Buffered, 30mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Green Tea (EGCG) Injectable, 10mg/mL,10mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

Magnesium Sulfate Injectable, 14.28%, 7mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

DMPS Injectable, 50mg/mL, 5mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

TNPRDC Injection, 6 mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

View recall →

Drug Recall Terminated Historical recordClass II

EDTA Calcium Disodium Injectable, 300mg/mL, 50mL vial, Rx only, Downing Labs, LLC 4001 McEwen Rd, Suite 110, Dallas TX, 754244, 1-800-914-7435

by Downing Labs, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
October 16, 2015
Reported by FDA
November 25, 2015
Distribution
Nationwide in the US; Australia, Brazil, Bahamas, Switzerland, France, Colombia, Hong Kong, Indonesia, India, Japan, Malaysia, New Zealand, Phillippines, Singapore, Thailand, Trinidad and Tobago, Taiwan

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.