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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 9,321–9,340 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass I

Blissful Remedies Red Maeng Da Liquid Kratom Mitragyna Speciosa, 12mL bottle. Distributed by World Organix LLC Las Vegas Nevada. UPC#7 14983 56525 7

by World Organix, LLC

Reason
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Recall initiated
June 26, 2018
Reported by FDA
August 15, 2018
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass I

Blissful Remedies, 4 Hour Chill, Slow Motion Blend, Herbal Shot. 1.93 Fluid Oz (57ml) UPC#6 02401 88900 3.

by World Organix, LLC

Reason
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Recall initiated
June 26, 2018
Reported by FDA
August 15, 2018
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass I

Blissful Remedies Red Maeng Da, 100% Mitragyna Speciosa capsule, 50-count packaged White Foil Pouche, Dist. by World Organix LLC, Las Vegas, Nevada UPC#7 22589 32355 3

by World Organix, LLC

Reason
Microbial Contamination of Non-Sterile Products: The firm is initiating a recall of some of its products due to the potential of high microbial loads.
Recall initiated
June 26, 2018
Reported by FDA
August 15, 2018
Distribution
Nationwide in the USA.

View recall →

Drug Recall Terminated Historical recordClass II

Dymista (azelastine hydrochloride and fluticasone propionate) Nasal Spray, 137 mcg / 50 mcg per spray, packaged in a 23 g net fill weight, Rx only, Manufactured by: Cipla Ltd., Goa, India, M.L.,, NDC 0037-0245-23

by Mylan Pharmaceuticals Inc.

Reason
Presence of foreign substance: Potential for glass in the neck area of the glass bottles.
Recall initiated
July 25, 2018
Reported by FDA
August 15, 2018
Distribution
U.S. Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Omega-3-Acid Ethyl Esters Capsules USP, 1 gram* 120-count bottle Rx Only. Manufactured by: Banner Pharmacaps, Inc. High Point, NC 27265. Manufactured for: Teva Pharmaceuticals USA Inc. North Wales, PA 19454 NDC 0093-5401-89

by Teva Pharmaceuticals USA

Reason
API material used in the manufacturing of the product did not receive regulatory approval prior to release.
Recall initiated
July 16, 2018
Reported by FDA
August 15, 2018
Distribution
Product was distributed throughout the United States

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Drug Recall Terminated Historical recordClass II

Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridgerate. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

View recall →

Drug Recall Terminated Historical recordClass II

Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247

by Guardian Pharmacy Services

Reason
Lack of sterility assurance.
Recall initiated
May 17, 2018
Reported by FDA
August 15, 2018
Distribution
Texas

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.