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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 7,601–7,620 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Gentamicin (GU) Irrigation 240 mg/500 mL Solution, 250 mL Container, Shake well and Refrigerate, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Recall initiated
July 22, 2019
Reported by FDA
August 7, 2019
Distribution
CO, TX, WY

View recall →

Drug Recall Terminated Historical recordClass II

Dexamethasone Sodium Phosphate PF 24 mg/mL Injection, Refrigerate, Single Use Vial, 1 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Recall initiated
July 22, 2019
Reported by FDA
August 7, 2019
Distribution
CO, TX, WY

View recall →

Drug Recall Terminated Historical recordClass II

Alprostadil 100 mcg/mL Injectable, 2.5 mL vial, Rx only, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Recall initiated
July 22, 2019
Reported by FDA
August 7, 2019
Distribution
CO, TX, WY

View recall →

Drug Recall Terminated Historical recordClass II

Acetylcysteine 2% Otic Drop, 15 mL bottle, Rx only, Refrigerate, Compounded by Wise Pharmacy, Littleton, CO 80123.

by Wise Pharmacy

Reason
Lack of Processing Controls
Recall initiated
July 22, 2019
Reported by FDA
August 7, 2019
Distribution
CO, TX, WY

View recall →

Drug Recall Terminated Historical recordClass II

Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet of 28 tablets) NDC 68180-903-13 (carton of 3 wallets)

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.
Recall initiated
July 2, 2019
Reported by FDA
August 7, 2019
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass III

Lemon Hand Sanitizer (Alcohol 62%), 30 mL / 1.0 fl.oz, OTC, Made in China.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

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Drug Recall Terminated Historical recordClass III

DIPPIN' DOTS SCENTED COTTON CANDY ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

View recall →

Drug Recall Terminated Historical recordClass III

DIPPIN' DOTS SCENTED COOKIES 'N CREAM ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

View recall →

Drug Recall Terminated Historical recordClass III

DIPPIN' DOTS SCENTED BIRTHDAY CAKE ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

View recall →

Drug Recall Terminated Historical recordClass III

DIPPIN' DOTS SCENTED BANANA SPLIT ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

View recall →

Drug Recall Terminated Historical recordClass III

ICEE BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

View recall →

Drug Recall Terminated Historical recordClass III

ICEE CHERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

View recall →

Drug Recall Terminated Historical recordClass III

ICEE PEACH SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

View recall →

Drug Recall Terminated Historical recordClass III

ICEE LEMON LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

View recall →

Drug Recall Terminated Historical recordClass III

AIR HEADS ORANGE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

View recall →

Drug Recall Terminated Historical recordClass III

AIR HEADS PINK LEMONADE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

View recall →

Drug Recall Terminated Historical recordClass III

AIR HEADS BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

View recall →

Drug Recall Terminated Historical recordClass III

AIR HEADS STRAWBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

View recall →

Drug Recall Terminated Historical recordClass III

TOOTSIE ROLL SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

View recall →

Drug Recall Terminated Historical recordClass III

TOOTSIE ROLL FRUIT CHEWS LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz / 40 mL, OTC, Distributed by: JFL Enterprises, Inc. Cleveland, Ohio 44102.

by NingBo Huize Commodity Co.,Ltd.

Reason
CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer OTC products.
Recall initiated
April 1, 2019
Reported by FDA
August 7, 2019
Distribution
Foreign manufacturer located in China and distributed to seven consignees located in China.

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.