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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 5,961–5,980 of 17,964 drug recalls

Drug Recall Completed Historical recordClass I

Tasty Drops Hemp Oil Extract, Natural, 1 FL. OZ (30ML) bottles, 500mg CBD, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29084 2

by MICHIGAN HERBAL REMEDIES

Reason
Chemical Contamination: product contains elevated levels of undeclared lead.
Recall initiated
June 18, 2020
Reported by FDA
August 12, 2020
Distribution
Nationwide via internet sales,retailers and distributors in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Fentanyl Citrate Inj., USP 100 mcg Fentanyl/2 mL (50 mcg/mL) 2 mL Single-dose Fliptop Vials, Rx only, Distributed by Hospira, Inc. Lake Forest, IL 60045 USA NDC 0409-9094-12

by Pfizer Inc.

Reason
Lack of Assurance of Sterility; potential loose metal overseal crimp defects.
Recall initiated
July 20, 2020
Reported by FDA
August 12, 2020
Distribution
United States including Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass I

KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By Summitt Labs, UPC 8 5765000812 8, www.KOREORGANIC.com 833.810.KORE.

by Summitt Labs

Reason
Chemical Contamination; product contains elevated levels of lead
Recall initiated
April 15, 2020
Reported by FDA
August 12, 2020
Distribution
Nationwide in the USA

View recall →

Drug Recall Completed Historical recordClass I

Tasty Drops, Hemp Oil Extract, Vanilla, 1500MG CBD,1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29086 6

by MICHIGAN HERBAL REMEDIES

Reason
Chemical contamination: product contains elevated levels of undeclared lead.
Recall initiated
June 18, 2020
Reported by FDA
August 12, 2020
Distribution
Nationwide via internet sales,retailers and distributors in the USA

View recall →

Drug Recall Completed Historical recordClass I

Acadia Farms, Serenity, soothing mint, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bottles, Distributed by: Acadia Farms, Rehobeth, Massachusetts

by MICHIGAN HERBAL REMEDIES

Reason
Chemical contamination: product contains elevated levels of undeclared lead.
Recall initiated
June 18, 2020
Reported by FDA
August 12, 2020
Distribution
Nationwide via internet sales,retailers and distributors in the USA

View recall →

Drug Recall Completed Historical recordClass I

Pathway To Wellness, CBD Oil, Premium Hemp Oil Drops, Natural, 1000MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Pathway to Wellness

by MICHIGAN HERBAL REMEDIES

Reason
Chemical contamination: product contains elevated levels of undeclared lead.
Recall initiated
June 18, 2020
Reported by FDA
August 12, 2020
Distribution
Nationwide via internet sales,retailers and distributors in the USA

View recall →

Drug Recall Completed Historical recordClass I

Javan Anti Aging and Wellness Institute, CBD Oil, Full Spectrum Hemp Oil, Spearmint, 300MG CBD, 1 FL. OZ (30 ML) bottles, Dist by: Javan Wellness LLC, 1445 Church St NW Unit 24, Washington, DC 20005

by MICHIGAN HERBAL REMEDIES

Reason
Chemical contamination: product contains elevated levels of undeclared lead.
Recall initiated
June 18, 2020
Reported by FDA
August 12, 2020
Distribution
Nationwide via internet sales,retailers and distributors in the USA

View recall →

Drug Recall Completed Historical recordClass I

BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Berry Blast, 500mg CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 146, Eau Claire, MI 49111

by MICHIGAN HERBAL REMEDIES

Reason
Chemical contamination: product contains elevated levels of undeclared lead.
Recall initiated
June 18, 2020
Reported by FDA
August 12, 2020
Distribution
Nationwide via internet sales,retailers and distributors in the USA

View recall →

Drug Recall Completed Historical recordClass I

Made by Hemp 1000MG Hemp Extract, French Vanilla, 1 OZ (30 ML) bottles, Dist by: MHR Brands, Jenison, MI, UPC 8 02991 76553 7

by MICHIGAN HERBAL REMEDIES

Reason
Chemical contamination: product contains elevated levels of undeclared lead.
Recall initiated
June 18, 2020
Reported by FDA
August 12, 2020
Distribution
Nationwide via internet sales,retailers and distributors in the USA

View recall →

Drug Recall Terminated Historical recordClass III

Clonazepam Orally Disintegrating Tablets, USP, 0.125 mg, 60-count bottle, Rx only, Mfg by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, NDC 57664-783-86

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason
Cross contamination with other products - OOS discovered during routine stability testing for highest unknown impurity later identified as clozapine
Recall initiated
July 6, 2020
Reported by FDA
August 5, 2020
Distribution
Nationwide USA

View recall →

Drug Recall Terminated Historical recordClass II

Yohimbine HCL 5.4mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

by MasterPharm LLC

Reason
Lack of Processing Controls (lack of assurance of conformity to specifications).
Recall initiated
July 2, 2020
Reported by FDA
August 5, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Vardenafil 20 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

by MasterPharm LLC

Reason
Lack of Processing Controls (lack of assurance of conformity to specifications).
Recall initiated
July 2, 2020
Reported by FDA
August 5, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Testosterone/Anastrozole Pellet 100/6 mg, 100 pellets per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419 (866) 630-5600

by MasterPharm LLC

Reason
Lack of Processing Controls (lack of assurance of conformity to specifications).
Recall initiated
July 2, 2020
Reported by FDA
August 5, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Tadalafil 7 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

by MasterPharm LLC

Reason
Lack of Processing Controls (lack of assurance of conformity to specifications).
Recall initiated
July 2, 2020
Reported by FDA
August 5, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Tadalafil 3 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

by MasterPharm LLC

Reason
Lack of Processing Controls (lack of assurance of conformity to specifications).
Recall initiated
July 2, 2020
Reported by FDA
August 5, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Tadalafil 26 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

by MasterPharm LLC

Reason
Lack of Processing Controls (lack of assurance of conformity to specifications).
Recall initiated
July 2, 2020
Reported by FDA
August 5, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Tadalafil 18 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

by MasterPharm LLC

Reason
Lack of Processing Controls (lack of assurance of conformity to specifications).
Recall initiated
July 2, 2020
Reported by FDA
August 5, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Tadalafil 12 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

by MasterPharm LLC

Reason
Lack of Processing Controls (lack of assurance of conformity to specifications).
Recall initiated
July 2, 2020
Reported by FDA
August 5, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Sildenafil 50 mg Troche, 30 troches per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

by MasterPharm LLC

Reason
Lack of Processing Controls (lack of assurance of conformity to specifications).
Recall initiated
July 2, 2020
Reported by FDA
August 5, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Progesterone Modified Release 200 mg Capsule, 90 capsules per bottle, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419, (866) 630-5600

by MasterPharm LLC

Reason
Lack of Processing Controls (lack of assurance of conformity to specifications).
Recall initiated
July 2, 2020
Reported by FDA
August 5, 2020
Distribution
Nationwide in the U.S.

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.