Class I · High risk
Octreotide Acetate Injection 500 mcg/mL
Presence of Particulate Matter: Product complaint for the presence of glass particles in a syringe.
Class I drug recalls - the high-risk category
Class I is the FDA's most serious recall category: a reasonable probability that using the product will cause serious health consequences or death. It is a small share of all recalls, but the one to check first if a medication you take appears here.
1,750 recalls, newest first.
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Class I · High risk
8.4% Sodium Bicarbonate Injection
Defective Container: Complaints received of vial breakage and glass flying when pressurized while preparing the product for administration
Class I · High risk
Atenolol Tablets
Label Mix - up; a bottle labeled as Atenolol 25mg Tablets contained Clopidogrel 75mg Tablets
Class I · High risk
Antica Farmacista Hand Sanitizer Ocean Citron
Chemical Contamination: product found to contain benzene
Class I · High risk
PROPOFOL Injectable Emulsion
Presence of particulate matter
Class I · High risk
Banana Boat hair & scalp defense
Chemical contamination: presence of benzene
Class I · High risk
SANGTER Energy Supplement Capsules
Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil.
Class I · High risk
SUSTANGO (Pendenadril Tytrate Blend)
Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil.
Class I · High risk
Walgreens
Microbial contamination of non-sterile products.
Class I · High risk
Walgreens
Microbial contamination of non-sterile products.
Class I · High risk
Topcare health
Microbial contamination of non-sterile products.
Class I · High risk
Swan
Microbial contamination of non-sterile products.
Class I · High risk
Rexall
Microbial contamination of non-sterile products.
Class I · High risk
P, magnesium citrate SALINE LAXATIVE
Microbial contamination of non-sterile products.
Class I · High risk
meijer
Microbial contamination of non-sterile products.
Class I · High risk
Kroger
Microbial contamination of non-sterile products.
Class I · High risk
EQUALINE magnesium citrate saline laxative
Microbial contamination of non-sterile products.
Class I · High risk
equate Magnesium Citrate
Microbial contamination of non-sterile products.
Class I · High risk
CVS Health
Microbial contamination of non-sterile products.
Class I · High risk
Propofol Injectable Emulsion
Presence of particulate matter: particulate identified as a beetle.
Class I · High risk
Insulin Glargine
Labeling: Missing label: Label missing from some prefilled pens.
Class I · High risk
Launch Sequence Aphrodisia Capsules
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
Launch Sequence Euphoria Capsules
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
Launch Sequence Capsules
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.