Class I · High risk Terminated
Topcare health
Reason Microbial contamination of non-sterile products.
FDA Drug Recalls
1,739 recalls · Class I, newest first
Class I · High risk Terminated
Swan
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
Rexall
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
P, magnesium citrate SALINE LAXATIVE
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
meijer
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
Kroger
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
EQUALINE magnesium citrate saline laxative
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
equate Magnesium Citrate
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
CVS Health
Reason Microbial contamination of non-sterile products.
Class I · High risk Terminated
Propofol Injectable Emulsion
Reason Presence of particulate matter: particulate identified as a beetle.
Class I · High risk Terminated
Insulin Glargine
Reason Labeling: Missing label: Label missing from some prefilled pens.
Class I · High risk Terminated
Launch Sequence Aphrodisia Capsules
Reason Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Terminated
Launch Sequence Euphoria Capsules
Reason Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Terminated
Launch Sequence Capsules
Reason Marketed Without An Approved NDA/ANDA: Product found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
Class I · High risk Terminated
Nifedipine WSP 0.2% Ointment
Reason Subpotent and Superpotent Drug
Class I · High risk Terminated
Morphine Sulfate extended-Release Tablets
Reason Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class I · High risk Terminated
Morphine Sulfate extended-Release Tablets
Reason Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets contain Morphine Sulfate 30 mg Extended-Release tablets and bottles labeled as Morphine Sulfate 30 mg Extended-Release tablets may contain Morphine Sulfate 60 mg Extended-Release tablets.
Class I · High risk Terminated
CVS Health Magnesium Citrate SALINE LAXATIVE
Reason Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of Gluconacetobacter Liquefaciens
Class I · High risk Terminated
Arti King Refozado con Ortiga y Omega 3 Tablets
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac and dexamethasone.
Class I · High risk Terminated
SnoreStop NasoSpray
Reason Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain microbial contamination identified as Providencia rettgeri.
Class I · High risk Terminated
Allergy Bee Gone for Kids Nasal Swab Remedy 0.33 FL OZ
Reason Microbial contamination of non-sterile product: FDA laboratory analysis found product to contain elevated levels of yeast and mold as well as the presence of Bacillus cereus.
Class I · High risk Terminated
Magnesium Hydroxide 2400 mg
Reason Microbial Contamination of Non-Sterile Products.
Class I · High risk Terminated
Magnesium Hydroxide 1200 mg
Reason Microbial Contamination of Non-Sterile Products.
Class I · High risk Terminated
Milk of Magnesia USP
Reason Microbial Contamination of Non-Sterile Products.
Class I · High risk Terminated
Milk of Magnesia USP
Reason Microbial Contamination of Non-Sterile Products