Class III means the product is unlikely to cause harm but violates FDA labeling or manufacturing rules. These are the recalls you rarely hear about; pharmacies usually just swap the affected lot.
1,716 recalls, newest first.
Labeling: incorrect or missing lot and/or expiration date. An incorrect expiration date was printed on the product labeling with an expiration date of January 2027, whereas the correct expiration date is September 2026.
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Failed Impurities/Degradation Specifications.
Failed Dissolution Specifications: Sirolimus Oral Solution recalled due to lot RZ1598 exceeded the specification limit at the 14-month timepoint.
Failed Dissolution Specifications: Nitrofurantoin Capsules recalled due to dissolution failure at 0-time of the repackaged lot. Drug release results were above specification at 0-time.
Mislabeling: The active ingredient list on the label does not match the product's actual ingredients Specifically, the label states Octinoxate 7.5% and Oxybenzone 3%, while the product therein is made with Octinoxate 7.5%, Octisalate 5%, Octocrylene 5%, and Avobenzone 3%.
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Subpotent drug: Low OOS for menthol content at the three month room temperature.
Failed viscosity specification - product was below specificcation
Does Not Meet USP or OTC Monograph: Product exceeds USP specification for alcohol content
cGMP deviations: Temperature abuse
Subpotent Drug: Out of specification for assay.
Subpotent Drug: Out of Specification results for Assay
Subpotent Drug and Presence of Particulate Matter: low out-of-specification results obtained for assay and the presence of particulate matter.
Subpotent
Labeling: Incorrect Barcode: Product barcode incorrectly identifies the product as rocuronium bromide injection 100 mg per 10 mL instead of sodium chloride injection 23.4%, 120 mEq per 30 mL.
Incorrect/Undeclared Excipient: Product contains alcohol
Subpotent Drug: low out-of-specification results for Vial 1 assay obtained during stability studies.
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
FAILED CONTENT UNIFORMITY SPECIFICATIONS
Sub Potent
Sub Potent