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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 3,341–3,360 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass II

Dextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets (Mixed Salts of a Single Entity Amphetamine Product), 15 mg, Rx Only, 100 tablets per bottle, Teva Pharmaceuticals USA, Inc. North Wales, PA 19454, NDC 0555-0777-02.

by Teva Pharmaceuticals USA Inc

Reason
Labeling: Label Error on Declared Strength; A sealed 100-count bottle labeled with 15 mg actually contained 100 tablets of 20 mg strength of the drug product.
Recall initiated
August 29, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the US.

View recall →

Drug Recall Terminated Historical recordClass II

Lisinopril 10 mg tablets, 30-count Blister Card, Rx Only, MFG: Lupin Pharma, Baltimore, MD Repackaged by: RemedyRepack Inc, Indiana PA. Original NDC# 68180-0980-03, Repackaged NDC# 70518-0468-00

by RemedyRePack Inc.

Reason
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Recall initiated
September 15, 2022
Reported by FDA
September 21, 2022
Distribution
Distributed to two direct accounts in PA and AK.

View recall →

Drug Recall Terminated Historical recordClass II

Synergy Hand Sanitizer, Non-Sterile Solution to help reduce bacteria that can potentially cause disease, For use when soap and water are not available, Alcohol 80% Topical Solution, Antiseptic, 8.5 oz./ 250 mL bottles, Made and Distributed by: Superior Glove Works Ltd., 36 Vimy Street, Acton, Ontario, L7J 1S1, Canada, Made in Canada, UPC: 779406201594.

by SUPERIOR GLOVE WORKS, LTD.

Reason
CGMP Deviations: FDA analysis found product to contain acetaldehyde impurity and the Sum of All Impurities, above specification limits.
Recall initiated
September 1, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the US.

View recall →

Drug Recall Terminated Historical recordClass II

Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-980-03

by Lupin Pharmaceuticals Inc.

Reason
Presence of Foreign Substance: Foreign material (metal piece) embedded in one tablet.
Recall initiated
September 13, 2022
Reported by FDA
September 21, 2022
Distribution
Product was distributed to major distributors/wholesalers nationwide.

View recall →

Drug Recall Completed Historical recordClass II

Triamcinolone Acetonide cream, 0.1%, 80 g tube, Rx only, Packaged and Distributed By: Direct Rx, Dawsonville, GA 30534, Dist. By Perrigo, Allegan, MI 49010, NDC 72189-330-80.

by Direct Rx

Reason
CGMP Deviations: Product complaints reporting the product to have a gritty texture and lack of effectiveness.
Recall initiated
September 12, 2022
Reported by FDA
September 21, 2022
Distribution
Physicians and Medical Facilities in GA and ID

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Drug Recall Completed Historical recordClass II

QUAD-MIX 30MG/3MG/60MCG/0.2 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Completed Historical recordClass II

QUAD-MIX 30/2/60/0.15 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Completed Historical recordClass II

TRI-MIX 50/2.5/25 Injectable, 2 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Completed Historical recordClass II

TRI-MIX 30/2/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Completed Historical recordClass II

TRI-MIX 30/2/20 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Completed Historical recordClass II

TRI-MIX 30/1/60 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Completed Historical recordClass II

TRI-MIX 30/1/40 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Completed Historical recordClass II

TRI-MIX 30/1/20 Injectable, 5 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Completed Historical recordClass II

TRI-MIX 30/1/10 Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Completed Historical recordClass II

TEST CYP/PROP (50:50) 100 MG/100 MG/ML Injectable, 12.6 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Completed Historical recordClass II

TEST CYP/DHEA (Sesame) 200 MG/2.5 MG/ML Injectable, 10 ML vial, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Completed Historical recordClass II

TEST CYP/DHEA (Sesame Oil) 100 MG/2.5 MG/ML Injection, 3 ML and 6 ML vials, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Completed Historical recordClass II

TEST CYP (Grapeseed) 200 MG/ML Injectable, 10 ML vial, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Completed Historical recordClass II

Semaglutide/Cyanocobalamin 24/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

View recall →

Drug Recall Completed Historical recordClass II

Semaglutide/Cyanocobalamin 10/2 MG/ML Injectable, 0.4 ML syringe, Rx only, Carolina Infusion LLC, 95 Bees Creek Road, Ridgeland, SC 29936.

by Carolina Infusion

Reason
Lack of Assurance of Sterility
Recall initiated
August 26, 2022
Reported by FDA
September 21, 2022
Distribution
Nationwide in the USA.

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.