17,898 recalls, newest first
Reason Marketed without an approved NDA/ANDA: FDA analysis found product to be tainted with undeclared acetaminophen, diclofenac, and phenylbutazone.
Reason Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Reason CGMP Deviations: Out of specification for dissolution
Reason CGMP Deviations: Manufactured without following Current Good Manufacturing Practises.
Reason CGMP Deviations and Presence of Particulate Matter: Glass
Reason Failed Dissolution Specifications
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Reason Subpotent drug: The potency of the active (menthol) was less than the label claim of 4%.
Reason Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
Reason Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Reason Sub-potent Drug
Reason Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrectly labeled with the drug facts label for Aspirin 81…
Reason Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason CGMP deviations
Reason This product is being recalled due to the tube weld failure presents itself as a slow leak and can be difficult to detect.
Reason Failed dissolution specifications: out of specification result obtained during routine stability testing for high dissolution.