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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 16,741–16,760 of 17,987 drug recalls

Drug Recall Terminated Historical recordClass III

Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 600 mg/60 mg, Wild Berry flavor, 35-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44840 4.

by Novartis Consumer Health

Reason
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Recall initiated
August 6, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide, Canada, and Panama.

View recall →

Drug Recall Terminated Historical recordClass III

Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, packaged in a) 35-count (NDC 0067-6279-35) (UPC 3 0067-0343-35 4); b) 65-count (NDC 0067-6279-65) (UPC 3 0067-0343-65 1); and c) 90-count (NDC 0067-6279-90) (UPC 3 0067-0343-90 3) tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622.

by Novartis Consumer Health

Reason
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Recall initiated
August 6, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide, Canada, and Panama.

View recall →

Drug Recall Terminated Historical recordClass III

Maalox Advanced Maximum Strength Antacid & Antigas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Wild Berry flavor, 65-count tablets per bottle, Distributed by: Novartis Consumer Health, Inc., Parsippany, NJ 07054-0622, NDC 0067-62791-65, UPC 3 0067-0376-65 9.

by Novartis Consumer Health

Reason
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Recall initiated
August 6, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide, Canada, and Panama.

View recall →

Drug Recall Terminated Historical recordClass III

Maalox Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wild Berry flavor, packaged in a) 50-count (UPC 0 58478 44825 1), b) 100-count (UPC 0 58478 44826 8) and c) 145-count (UPC 0 58478 44836 7) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290.

by Novartis Consumer Health

Reason
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Recall initiated
August 6, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide, Canada, and Panama.

View recall →

Drug Recall Terminated Historical recordClass III

Mavik¿ trandolapril tablets 4mg, 100 count bottle, Rx only, Manufactured by Halo Pharmaceutical Inc., Whippany, NJ for Abbott Laboratories, North Chicago, IL 60064, USA

by AbbVie Inc.

Reason
Labeling: Incorrect Package Insert; product packaged with outdated version of the insert
Recall initiated
August 1, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

CLENZIderm M.D. Acne Therapeutic System Normal to Oily Skin kit, Distributed by OMP, Inc., Long Beach, CA 90806, Kit is comprised of: Daily Care Foaming Cleanser (Salicylic Acid 2%) NDC 62032-111; Pore Therapy (Salicylic Acid 2%) NDC 62032-110 and Therapeutic Lotion (Benzoyl Peroxide 5%) NDC 562032-113). Product under recall is the Pore Therapy (Salicylic Acid 2%), NDC 62032-110.

by Medicis Pharmaceutical Corp

Reason
cGMP Deviations; during the production process, CLENZIderm M.D. Daily Foam Cleanser was filled into some bottles labeled as CLENZIderm M.D. Pore Therapy
Recall initiated
May 1, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide, Great Britain, Mexico, Russia and The Ukraine.

View recall →

Drug Recall Terminated Historical recordClass II

IRINOTECAN HYDROCHLORIDE INJECTION, 40 mg/2 mL (20 mg/mL), 2 mL Single Dose Vial, Rx only, Manufactured for: APP Pharmaceuticals, LLC, Schaumburg, IL 60173, NDC 63323-193-02, UPC 3 63323 19302 7.

by Fresenius Kabi USA LLC (FK USA)

Reason
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Recall initiated
January 22, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Tagitol V Barium Sulfate Suspension (40% w/v, 30% w/w) Net Contents: 20 mL, (NDC 32909-814-53) Rx Only, Manufactured by E-Z-EM Canada Inc., a subsidiary of E-Z-EM, Inc. Lake Success, NY 11042 Tel: 1-516-333-8230 1-800-544-4624 NDC 32909-814-53

by Bracco Diagnostics Inc

Reason
Failed Stability Specifications: Tagitol V Barium Sulfate Lot #65846 sampled at 10 months exhibited results above the upper specification for viscosity.
Recall initiated
July 19, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Eyebright Concentrate Topical Eye Rinse, 1, 2, 4, 8, 16 & 32 fl oz bottles, Produced and distributed by: Wise Woman Herbals, Creswell, OR

by Earthlabs, Inc. DBA Wise Woman Herbals

Reason
Lack of Assurance of Sterility; Lack of Assurance of Sterility; product not manufactured under sterile conditions as required for ophthalmic drug products
Recall initiated
May 27, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass III

Braintree HalfLytely and Bisacodyl Tablet Bowel Prep Kit (Rx) NDC 52268-523-02

by Braintree Laboratories Inc.

Reason
Defective Container; Small micro fracture observed in the 2-Liter bottle at the fill line resulting in a small leak when patient reconstitutes the bulk powder
Recall initiated
July 15, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwie

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Drug Recall Terminated Historical recordClass III

Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Cherry flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10090 6.

by Novartis Consumer Health

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Recall initiated
August 6, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide, Canada, and Panama.

View recall →

Drug Recall Terminated Historical recordClass III

Maalox Nighttime Antacid with Acid Reflux Barrier (calcium carbonate and alginic acid) chewable tablets, 500 mg/200 mg, Mint flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 80000899, UPC 0 58478 10091 3.

by Novartis Consumer Health

Reason
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Recall initiated
August 6, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide, Canada, and Panama.

View recall →

Drug Recall Terminated Historical recordClass III

Maalox, Regular Strength Antacid (calcium carbonate) chewable tablets, 600 mg, Wintergreen flavor, 50-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238290, UPC 0 58478 44824 4.

by Novartis Consumer Health

Reason
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Recall initiated
August 6, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide, Canada, and Panama.

View recall →

Drug Recall Terminated Historical recordClass III

Maalox Extra Strength Antacid (calcium carbonate) chewable tablets,1000 mg, Wild Berry flavor, packaged in a) 35-count (UPC 0 58478 44829 9) and b) 65-count (UPC 0 58478 44842 8) tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, NPN 02238291.

by Novartis Consumer Health

Reason
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Recall initiated
August 6, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide, Canada, and Panama.

View recall →

Drug Recall Terminated Historical recordClass III

Maalox Extra Strength Antacid with Anti-Gas (calcium carbonate and simethicone) chewable tablets, 1000 mg/60 mg, Assorted Fruit flavor, 65-count tablets per bottle, Novartis Consumer Health Canada Inc., Mississauga, ON L5N 2X7, foreign labeling containing English and French, DIN 02243496, UPC 0 58478 44872 5.

by Novartis Consumer Health

Reason
Labeling: Incorrect Or Missing Lot and/or Exp Date: The lot number and/or expiration date may be illegible on the outer plastic bottle packaging.
Recall initiated
August 6, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide, Canada, and Panama.

View recall →

Drug Recall Terminated Historical recordClass III

Nata Komplete, containing one 30-count bottle of multi-vitamin tablets (imprinted 909), Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-909-30) and physician samples of nine bottles of 5-multi-vitamin tablets (NDC 76331-909-05 )

by Stayma Consulting Service, LLC.

Reason
Subpotent; Beta carotene (Vitamin A)
Recall initiated
June 28, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Duet DHA 430 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-810-30)

by Stayma Consulting Service, LLC.

Reason
Subpotent; Beta carotene (Vitamin A)
Recall initiated
June 28, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Duet DHA 430, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Manufactured for W.H. Nutritionals, Wilmington, DE --- NDC 76331-808-30

by Stayma Consulting Service, LLC.

Reason
Subpotent; Beta carotene (Vitamin A)
Recall initiated
June 28, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

NataChew, 1) one 90-count bottle of multi-vitamin tablets (imprinted 902), (NDC 44118-902-90) and 2) physician samples containing nine bottles with 5 multi-vitamin tablets (imprinted 902) (NDC 44118-902-05), Manufactured for Eckson Labs, Wilmington, DE

by Stayma Consulting Service, LLC.

Reason
Subpotent; Beta carotene (Vitamin A)
Recall initiated
June 28, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass III

Duet DHA 400 ec, containing one 30-count bottle of multi-vitamin tablets (imprinted 800) and one 30-count bottle of Omega-3 softgel capsules, Rx only, Manufactured for Eckson Labs, Wilmington, DE (NDC 44118-809-30) and Manufactured for W.H. Nutritionals, Wilmington, DE (NDC 76331-809-30)

by Stayma Consulting Service, LLC.

Reason
Subpotent; Beta carotene (Vitamin A)
Recall initiated
June 28, 2013
Reported by FDA
August 28, 2013
Distribution
Nationwide.

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.