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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 5,101–5,120 of 17,937 drug recalls

Drug Recall Terminated Historical recordClass III

Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(NDC 52565-033-60) Rx Only, Manufactured by: Teligent Pharma, Inc. , Buena, NJ 08310,

by Teligent Pharma, Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
June 22, 2021
Reported by FDA
July 28, 2021
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59

by Teligent Pharma, Inc.

Reason
Failed Impurities/Degradation Specifications
Recall initiated
June 22, 2021
Reported by FDA
July 28, 2021
Distribution
Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

Thumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC

by Nuri Trading LLC

Reason
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil sildenafil, and vardenafil, FDA approved drugs making them an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.
Recall initiated
March 29, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

Thumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC

by Nuri Trading LLC

Reason
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil, an FDA approved drug making this an unapproved drug for which the safety and efficacy has not been established and therefore subject to recall.
Recall initiated
March 29, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Ongoing Historical recordClass I

Shogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC

by Nuri Trading LLC

Reason
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Recall initiated
March 29, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Goose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 814630 02423 3

by Scentsational Soaps & Candles Inc

Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Recall initiated
April 27, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02045 7

by Scentsational Soaps & Candles Inc

Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Recall initiated
April 27, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 14630 02424 0

by Scentsational Soaps & Candles Inc

Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Recall initiated
April 27, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Goose Creek Hand Sanitizer aloe Marshmallows, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01331 8

by Scentsational Soaps & Candles Inc

Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Recall initiated
April 27, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd., Liberty, KY 42539, UPC 8 18489 01332 5

by Scentsational Soaps & Candles Inc

Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Recall initiated
April 27, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Goose Creek Hand Sanitizer aloe Limoncello, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL),Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 18489 01333 2

by Scentsational Soaps & Candles Inc

Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Recall initiated
April 27, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Goose Creek Hand Sanitizer aloe Blueberry Limeade, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandle.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 14630 02049 5

by Scentsational Soaps & Candles Inc

Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Recall initiated
April 27, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

SS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection

by Scentsational Soaps & Candles Inc

Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Recall initiated
April 27, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection

by Scentsational Soaps & Candles Inc

Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Recall initiated
April 27, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL), a) Black and White Collection; b) Photo Real Collection

by Scentsational Soaps & Candles Inc

Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Recall initiated
April 27, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Ulta beauty Fresh Lemon Citron Frais, 70% Alcohol Hand Sanitizer Spray, Net Wt. 100.55/3.4 fl. oz., UPC 717897092017

by Scentsational Soaps & Candles Inc

Reason
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
Recall initiated
April 27, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 50 Coated Tablets/ 500 mg each, Distributed by Amerisource Bergen, 1300 Morris Drive, Chesterbrook, PA, 19087, NDC 46122-649-71

by LNK International, Inc.

Reason
Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the tablet is not enteric coated and should only say 'coated tablet'
Recall initiated
July 7, 2021
Reported by FDA
July 28, 2021
Distribution
Distributed in PA

View recall →

Drug Recall Terminated Historical recordClass I

Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count boxes, Manufactured by: SUM MARKETING LLC, Made in USA UPC 746695241860

by Ummzy, LLC

Reason
Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sildenafil and vardenafil making them unapproved drugs for which the safety and efficacy have not been established and therefore subject to recall.
Recall initiated
March 30, 2021
Reported by FDA
July 28, 2021
Distribution
USA Nationwide

View recall →

Drug Recall Terminated Historical recordClass I

Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitizer, packaged in a) (16.9oz) 500 mL (UPC 8 60003 31899 7, NDC: 73891-100-14); and b) (20oz) 591 mL (UPC 8 60003 65984 7 NDC: 73891-100-15) bottles, Prairie Wolf Distillery, Guthrie, Oklahoma

by Prairie Wolf Spirits

Reason
Hand sanitizer packaged in bottles that resemble beverage containers.
Recall initiated
June 21, 2021
Reported by FDA
July 21, 2021
Distribution
Nationwide in the US

View recall →

Drug Recall Ongoing Historical recordClass I

Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured in Dominican Republic: by Ardil Comercial S.R.L., Santo Domingo, Dominican Republic UPC 7 487040 301587

by Ardil Comercial S.R.L.

Reason
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
Recall initiated
June 22, 2021
Reported by FDA
July 21, 2021
Distribution
Product was distributed to one client in NYC who further distributed the product.

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.