17,898 recalls, newest first
Reason Presence of foreign substance: metallic razor blade was found in one bottle.
Reason Failed Content Uniformity Specifications
Reason Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag.
Reason Presence of Particulate Matter; white particulate matter identified as mold was found in one bag
Reason Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Reason Failed Stability Specifications:stability failure at 12 months, long term RT conditions.
Reason Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium.
Reason Subpotent Drug
Reason Subpotent Drug
Reason Presence of particulate matter
Reason CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer.
Reason Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap
Reason Failed Stability Specifications
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Reason GMP Deviations: manufacturing of API material did not meet GMP and quality requirements.
Reason Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during…
Reason Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
Reason Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia
Reason Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica…
Reason Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine.
Reason Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.
Reason Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area.