1,739 recalls · Class I, newest first
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Reason Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undeclared diclofenac.
Reason Marketed Without An Unapproved NDA/ANDA: Product lot found to be tainted with undeclared diclofenac, an FDA approved nonsteroidal anti-inflammatory…
Reason Superpotent: High Out of specification (OOS) test result for percent label claim (%LC).
Reason Failed Dissolution Specifications- Low Out-Of-Specification results obtained during stability testing.
Reason Subpotent drug
Reason Subpotent drug
Reason Labeling: Missing label on the vial
Reason TEMPERATURE ABUSE: Products were exposed to temperatures outside of the products labeled storage conditions due to inclement weather.
Reason Chemical contamination: presence of benzene
Reason Chemical Contamination; FDA analysis found product to contain benzene
Reason Chemical Contamination; FDA analysis found product to contain methanol
Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products…
Reason Presence of Particulate Matter: Product was found to contain silica and iron oxide
Reason Microbial Contamination of Non-Sterile Products
Reason Microbial Contamination of Non-Sterile Products
Reason Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Reason Defective Delivery System: Potential clogging of the needle preventing the dispensing of epinephrine.
Reason Labeling: Label mix-up: Incorrect label placed on product. Shipper cases labeled Meclizine Hydrochloride Tablets contain bottles incorrectly labeled…
Reason Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli.
Reason Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon…
Reason Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
Reason Chemical contamination: Presence of benzene
Reason Chemical contamination: Presence of benzene