Drug and pharmaceutical recalls
17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2021-07-28FDA-DrugTeligent Pharma, Inc.Class IIIErythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., Buena, NJ 08310, NDC 52565-027-59
Failed Impurities/Degradation Specifications
- 2021-07-28FDA-DrugNuri Trading LLCClass I69MODE Blue 69 capsule, packaged in 10-count box, Nuri Trading LLC
Marketed Without An Approved NDA/ANDA: Product found to be tainted with undeclared tadalafil and sildenafil, two FDA approved drugs making it an unapproved drug for which the safety and efficacy have not been established and therefore subject to recall.
- 2021-07-28FDA-DrugNuri Trading LLCClass IThumbs Up 7 White 11K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
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.
- 2021-07-28FDA-DrugNuri Trading LLCClass IThumbs Up 7 Black 25K capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
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.
- 2021-07-28FDA-DrugNuri Trading LLCClass IShogun-X 7000 capsule, packaged in a) 1-count blister card and b) 10-count box, Nuri Trading LLC
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.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass ICoconut Stand CoCo TKO Hand Sanitizer, Totally Knocks Out 99.9% of Germs, 3.4 FL. OZ. (100.55 mL), Distributed by: Beauty Sparks LLC St. Petersburg, FL 33711
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Tropical Daydream, 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 01335 6
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose 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
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose 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
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Optimistic Vibes, 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 02234 5
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose 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
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose 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
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose 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
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Champagne Bubbles, 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 01334 9
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Grape Soda, 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 01328 8
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose Creek Hand Sanitizer aloe Beach Dreams, Anti-Bacterial Spray, 3.38 FL. OZ. (100 mL), Goose Creek www.GooseCreekCandles.com, 1498 S. Wallace Wilkinson Blvd. Liberty, KY 42539, UPC 8 18489 01336 3
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose 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
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IGoose 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
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass ISS 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
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass ISS 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
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass ISS Lavender & Herbs Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL) a) Black and White Collection; b) Photo Real Collection
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass ISS 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
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass ISS Coconut Breeze Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical Solution, 3.38 FL. OZ. (100 mL), a) Black and White Collection; b) Photo Real Collection
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugScentsational Soaps & Candles IncClass IUlta beauty Fresh Lemon Citron Frais, 70% Alcohol Hand Sanitizer Spray, Net Wt. 100.55/3.4 fl. oz., UPC 717897092017
Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene and acetaldehyde.
- 2021-07-28FDA-DrugLNK International, Inc.Class IIIAcetaminophen 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
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'
- 2021-07-28FDA-DrugUmmzy, LLCClass IThumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in USA, UPC 617135894680.
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.
- 2021-07-28FDA-DrugUmmzy, LLCClass IShogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, Made in USA, UPC 118122030185
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.
- 2021-07-28FDA-DrugUmmzy, LLCClass IKrazy 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
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.
- 2021-07-21FDA-DrugPrairie Wolf SpiritsClass IPrairie 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
Hand sanitizer packaged in bottles that resemble beverage containers.
- 2021-07-21FDA-DrugArdil Comercial S.R.L.Class ILimar 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
Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking water bottles.
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