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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 5,921–5,940 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass III

Clobetasol Propionate Cream, USP, 0.05%, packaged in a)15g Tubes (NDC 60429-902-15) and b) 45g Tubes (NDC 60429-902-45), Rx Only, Mfd. by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada, Marketed by: Golden State Medical Supply Inc. Camarillo, CA 93012.

by Golden State Medical Supply Inc.

Reason
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Recall initiated
July 24, 2020
Reported by FDA
August 19, 2020
Distribution
Nationwide within the United States

View recall →

Drug Recall Terminated Historical recordClass III

Clobetasol Propionate Cream USP, 0.05%, a) 15 g tube, NDC: 60429-902-15; b) 45 g tube, NDC: 60429-902-45, Rx Only, For External Use Only, Not for Ophthalmic Use, Mfd by: Taro Pharmaceuticals Inc. Brampton, Ontario, Canada L6T 1C1, Marketed by: Golden State Medical Supply, Inc. Camarillo, CA 93012.

by Taro Pharmaceuticals U.S.A., Inc.

Reason
Failed Content Uniformity: bulk lot used to make these two lots was found to have failed content uniformity.
Recall initiated
July 20, 2020
Reported by FDA
August 19, 2020
Distribution
Nationwide in the U.S.

View recall →

Drug Recall Terminated Historical recordClass II

Heparin Sodium 5,000 units in 0.9% Sodium Chloride 1000 mL bag (5 units/mL), Rx only, SCA Pharmaceuticals 755 Rainbow Rd. Windsor, CT 06095, NDC 70004-0650-46

by SCA Pharmaceuticals

Reason
Subpotent Drug: Out-of-Specification potency results at the 30-day stability timepoint.
Recall initiated
July 29, 2020
Reported by FDA
August 19, 2020
Distribution
Product was distributed nationwide within the United States.

View recall →

Drug Recall Terminated Historical recordClass II

Nystatin Oral Suspension, USP 100,000 units per mL, Cherry/Peppermint Flavor, 16 fl. oz. (473 mL), Rx only, Pharmaceutical Associates, Inc. Greenville, SC 29605, NDC 0121-0810-16

by PAI Holdings, LLC. dba Pharmaceutical Associates Inc

Reason
Subpotent drug: Out of specification for assay at the 15-month test interval.
Recall initiated
August 4, 2020
Reported by FDA
August 19, 2020
Distribution
Nationwide USA

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Drug Recall Terminated Historical recordClass II

Lidocaine Patch 5%, packaged in 30-count cartons, Rx only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-3525-30

by Teva Pharmaceuticals USA

Reason
Labeling: Incorrect or Missing Lot and/or Exp date on the individual transdermal pouches but not in the carton.
Recall initiated
July 14, 2020
Reported by FDA
August 19, 2020
Distribution
Nationwide United States

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Drug Recall Terminated Historical recordClass III

Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724, NDC 0054-4497-10

by West-Ward Columbus Inc

Reason
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Recall initiated
July 22, 2020
Reported by FDA
August 19, 2020
Distribution
OH and MS

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Drug Recall Terminated Historical recordClass I

Lemon Blossom Hand Sanitizer (benzalkonium chloride 0.1% - antimicrobial), For Institutional and Industrial Use Only, a) foamyiQ 42.27 oz/1250 mL cartridge, UPC code: 7 53727 26454 4; b) Lite 'n Foamy 1 gallon/3.79 L container UPC code: 7 53727 26113 0, Spartan Chemical Company, Inc., 1110 Spartan Drive, Maumee, OH 43537 USA.

by Spartan Chemical Co Inc

Reason
Microbial contamination of non-sterile products: positive microbial contamination in product.
Recall initiated
July 1, 2020
Reported by FDA
August 12, 2020
Distribution
Nationwide USA, Panama, St. Maarten

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Drug Recall Terminated Historical recordClass II

VILEVEV MB Urinary Antispetic (81.0 mg methenamine, 40.8 mg sodium phosphate monobasic and 10.8 mg methylene blue, 0.12 mg hyoscyamine sulfate and 32.4 mg phenyl salicylate), Rx Only, 90 Tablets per Bottle, Manufactured for: Vilvet Pharmaceuticals, Inc., Chester Springs, PA 19425, NDC 71186-000-24.

by Vilvet Pharmaceuticals Inc.

Reason
cGMP deviations
Recall initiated
July 24, 2020
Reported by FDA
August 12, 2020
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

VILAMIT MB (118 mg methenamine, 36 mg phenyl salicylate, 40.8 mg sodium phosphate monobasic, 10.0 mg methylene blue and 0.12 mg hyoscyamine sulfate), Rx Only, 100 Capsules per Bottle, Manufactured for: Vilvet Pharmaceuticals Inc., Chester Springs, PA 18425, NDC 71186-002-35.

by Vilvet Pharmaceuticals Inc.

Reason
cGMP deviations
Recall initiated
July 24, 2020
Reported by FDA
August 12, 2020
Distribution
Nationwide within the US

View recall →

Drug Recall Terminated Historical recordClass II

Tropical Lip Moisturizer, SPF 30, UVA/UVB Lip Protection, Active Ingredients: Oxybenzone 5%, Octisalate 5%, Octinoxate 7.5%, Meradimate 5%, Made in USA

by Yusef Manufacturing Laboratories, LLC

Reason
Superpotent Drug: The beginning portion of the batch appears to be approximately 25% superpotent for active ingredient Meradimate.
Recall initiated
June 13, 2020
Reported by FDA
August 12, 2020
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Daptomycin for Injection, 500 mg/vial, Single-Dose Vial, Rx only, Sterile, Manufactured for: Mylan Institutional, LLC, Rockford, IL 61103 USA, NDC 67457-813-50

by Mylan Institutional LLC

Reason
Presence of Particulate Matter
Recall initiated
July 7, 2020
Reported by FDA
August 12, 2020
Distribution
USA Nationwide

View recall →

Drug Recall Completed Historical recordClass I

Herbzeedy, Hemp Oil Full Spectrum, Natural, 1500 MG CBD, 1 FL OZ (30 ML) bottles, Distributed by: Herbzeedy, Statesboro, GA

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

Goodness Gurus, Healthy Hemp Drops, 1500 MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 6 53341 99411 0

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

Goodness Gurus, Healthy Hemp Drops Full Strength, 1000 MG/Spearmint, 1 FL. OZ bottles, Distributed by: Goodness Gurus, Inc., Carlisle, PA, UPC 53341 99311 3

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, Natural, 1000MG CBD, 1 FL. OZ (30 ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, 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

BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil , Berry Blast, 1000MG CBD, 1 FL. OZ (30ML) bottles, Distributed by: B.C. Hemp Co., LLC, P.O. Box 156, 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

Tasty Drops, Hemp Oil Extract, Vanilla, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29082 8

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

Tasty Drops, Hemp Oil Extract, Spearmint, 1500MG CBD,1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29085 9

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

Tasty Drops, Hemp Oil Extract, Spearmint, 1000MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 8 02991 76539 1

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

Tasty Drops, Hemp Oil Extract, Spearmint, 500MG CBD, 1 FL. OZ (30ML) bottles, Dist by: Tasty Hemp Oil, Jenison, MI, UPC 6 96305 29081 1

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 →

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.