Every FDA drug recall initiated in 2018, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
1,681 recalls, newest first.
Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops, Nausea Drops, Intestinal Colic Drops, Stomach Calm, Expectorant Cough Syrup, Silver-Zinc Throat Spray, and Argentum Elixir, within expiry, due to lack of adequate controls during manufacturing.
Defective delivery system
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
Subpotent Drug: High Levels of Impurities Resulting in Decrease Potency
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbial count in a water sample.
Failed Stability Specifications
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
Subpotent
Subpotent
GMP Deviations
GMP Deviations
GMP Deviations
Microbial Contamination of Non-sterile Product