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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 15,241–15,260 of 17,987 drug recalls

Drug Recall Completed Historical recordClass II

Tatiomax (reduced glutathione/hydrolyzed collagen) powder for injection vials, 1200 mg/200 mg, 10-count vials per box, Manufactured by: Sujie Pharmaceutical Ltd., Tokyo, Japan, UPC 4973430081576

by Flawless Beauty LLC

Reason
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Recall initiated
April 29, 2014
Reported by FDA
May 21, 2014
Distribution
Nationwide

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Drug Recall Completed Historical recordClass II

Laroscorbine Platinium (vitamin C/collagen) injectable I.V. solution, 1 gm/0.35 gm, 5 mL ampoules, packaged in 10-count ampoules per box, Laboratories Roche Nicholas S.A., F-74240 Gaillard, - Tel.: 04 50 87 70 70, Fabricant : Produits Roche, 52, Bld du Parc, 92521 Neulilly -sur-Seine Cedex, barcode *3421357*

by Flawless Beauty LLC

Reason
Marketed Without An Approved NDA/ANDA: Product is sold over the counter whose labeling includes drug claims to act as an antidote.
Recall initiated
April 29, 2014
Reported by FDA
May 21, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

PSYLLIUM FIBER, Laxative/Supplement, 100 Capsules, OTC. Manufactured By: Konsyl Pharmaceuticals, Inc., Easton, MD 21601. NDC: 0224-1847-10.

by Konsyl Pharmaceuticals Inc

Reason
Labeling: Label Error on Declared Strength; Listed active ingredient strength is inaccurate.
Recall initiated
April 1, 2014
Reported by FDA
May 21, 2014
Distribution
USA including FL, MN, NY, OH, OR, PA, TX, SC and Puerto Rico; Dominican Republic.

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Drug Recall Terminated Historical recordClass II

INDOMETHACIN Capsules USP, 50 mg, a) 100 count bottle, (NDC 0093-4030-01), b) 500 count bottle, (NDC 0093-4030-05), Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960

by Teva Pharmaceuticals USA

Reason
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements.
Recall initiated
March 24, 2014
Reported by FDA
May 21, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

INDOMETHACIN Capsules USP, 25 mg 100 count bottle, Rx only , Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-4029-01

by Teva Pharmaceuticals USA

Reason
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Recall initiated
March 24, 2014
Reported by FDA
May 21, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

GLYBURIDE and METFORMIN HYDROCHLORIDE Tablets USP, 5mg/500mg, 500 count bottle, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC: 0093-5712-05

by Teva Pharmaceuticals USA

Reason
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Recall initiated
March 24, 2014
Reported by FDA
May 21, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

METHYLDOPA Tablets USP, 500 mg, 100 count bottle, Rx only, Manufactured In INDIA By: EMCURE PHARMACEUTICALS LTD harmaceuticals Ltd., Hinjwadi, Pune, India, Manufactured For: TEVA PHARMACEUTICALS USA, Sellersville, PA 18960, NDC 0093-2932-01

by Teva Pharmaceuticals USA

Reason
CGMP Deviations; laboratory testing was not followed in accordance with GMP requirements
Recall initiated
March 24, 2014
Reported by FDA
May 21, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Mercaptopurine Tablets USP, 50 mg, 25 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4581-11

by Boehringer Ingelheim Roxane Inc

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
Recall initiated
April 4, 2014
Reported by FDA
May 14, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Azathioprine Tablets USP, 50 mg, 100 count bottle, Rx only, Roxanne Laboratories, Inc., Columbus, Ohio, 43216, NDC 0054-4084-25

by Boehringer Ingelheim Roxane Inc

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: This recall is being conducted because the product was given 36 month expiration dates instead of the filed 24 months.
Recall initiated
April 4, 2014
Reported by FDA
May 14, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (NDC 66582-323-30), b) 90 count blister (NDC 66582-323-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889

by Merck & Co Inc

Reason
Defective Container; some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Recall initiated
January 13, 2014
Reported by FDA
May 14, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (NDC 66582-322-30), b) 90 count blister (NDC 66582-322-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889

by Merck & Co Inc

Reason
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Recall initiated
January 13, 2014
Reported by FDA
May 14, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (NDC 66582-321-30), b) 90 count blister (NDC 66582-321-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889

by Merck & Co Inc

Reason
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Recall initiated
January 13, 2014
Reported by FDA
May 14, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass III

Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (NDC 66582-320-30), b) 90 count blister (NDC 66582-320-54), Rx only, Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc, Whitehouse Station, NJ 08889

by Merck & Co Inc

Reason
This recall of LIPTRUZET is being initiated due to packaging defects. Some of the outer laminate foil pouches allowed in air and moisture, which could potentially decrease the effectiveness or change the characteristics of the product.
Recall initiated
January 13, 2014
Reported by FDA
May 14, 2014
Distribution
Nationwide and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Mangiacotti - Ginger Lime Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005351, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.

by Mangiacotti

Reason
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Recall initiated
December 27, 2013
Reported by FDA
May 14, 2014
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass II

Mangiacotti - Pomegranate Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005344, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.

by Mangiacotti

Reason
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Recall initiated
December 27, 2013
Reported by FDA
May 14, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Mangiacotti - Clementine Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005337, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.

by Mangiacotti

Reason
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Recall initiated
December 27, 2013
Reported by FDA
May 14, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Mangiacotti - Ocean Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005320, Active Ingredient Benzalkonium Chloride 0.1%, Dist By: Mangiacotti, Attleboro, MA 02703.

by Mangiacotti

Reason
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Recall initiated
December 27, 2013
Reported by FDA
May 14, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Mangiacotti - Lavender Hand Sanitizer Spray, alcohol free, 0.5 fl Oz. 15 mL spray bottle, UPC 870678005313, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703 .

by Mangiacotti

Reason
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Recall initiated
December 27, 2013
Reported by FDA
May 14, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Mangiacotti - Lemon Verbena Hand Sanitizer Spray, alcohol free, 0.5 fl. Oz., 15 mL spray bottle, UPC 870678005306, Active Ingredient Benzalkonium Chloride 0.1%, Dist by: Mangiacotti, Attleboro, MA 02703.

by Mangiacotti

Reason
Microbial Contamination of Non-Sterile Products: Elevated counts of bacteria was found, Serratia liquefaciens.
Recall initiated
December 27, 2013
Reported by FDA
May 14, 2014
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Tablets USP 1000 mg, 500 tablets Rx Only, Manufactured by Blu Caribe Dorado PR 00646. Distributed by Blu Pharmaceuticals Franklin NY 42134, NDC 24658-0292-05

by Blu Pharmaceuticals Inc

Reason
Defective container: Product distributed without inner seal on bottles.
Recall initiated
March 13, 2014
Reported by FDA
May 14, 2014
Distribution
NJ, UT, IL and CT

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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.