Drug Recalls
Recent drug recall reports from the FDA (US) and Health Canada, newest first. Each entry links to the full record -- product description, reason for recall, and severity classification -- refreshed daily.
MAIN PRODUCTS INC
Marketed without Approved NDA/ANDA. FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
FDC Limited
Defective container; yellow colored spike from cap lodged in the nozzle
Luscious Eyelash & Eyebrow Growth Serum
Product safety. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health con…
SoloVital
Marketed without an Approved NDA/ANDA: FDA analysis found product to be tainted with undeclared Diclofenac and Omeprazole.
Supercore Products Group Inc.
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Supercore Products Group Inc.
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Aurobindo Pharma USA Inc
Labeling: Missing Label - some bottles are missing the the manufacturers label that includes the drug facts information.
Endo Pharmaceuticals, Inc.
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled as 0.125 mg instead of 0.25 mg. The blister strips inside the product carton r…
SUN PHARMACEUTICAL INDUSTRIES INC
Failed Dissolution Specifications
Hikma Pharmaceuticals USA Inc.
Labeling: Label Mix-up: a bag of Dexmedetomidine HCl in 0.9% Sodium Chloride Injection was found inside an overwrap labeled Acetaminophen Injection 1,000 mg per…
Budesonide, USP
Product safety. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health con…
Novel Laboratories, Inc. d.b.a Lupin Somerset
Defective container: potential for non-sealed pouches which can lead to product leakage.
Cipla Omnigel Spray
Unauthorized product. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any heal…
Uriexo
Unauthorized product. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any heal…
Teva Pharmaceuticals USA, Inc
Failed Impurities/Degradation Specifications: Product is being recalled due to API related substances and unknown impurities that are above the specification li…
Glenmark Pharmaceuticals Inc., USA
Failed Dissolution Specifications: results below specifications
Zydus Pharmaceuticals (USA) Inc
Presence of particulate matter: glass
Suntegrity Impeccable Skin Sunscreen Foundation
Contamination. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health conc…
Teva-Topilene 0.05% Ointment
Product quality. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health co…
RemedyRepack Inc.
CGMP Deviations: Out of specification for dissolution
Dr. Reddy's Laboratories, Inc.
Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Guru Inc.
Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Nomad Hand Sanitizer
Product quality. Verify if your product is affected.Consult your healthcare provider prior to discontinuing use of the affected product(s), or for any health co…
GLOBAL WIDGET LLC
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
GLOBAL WIDGET LLC
Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.