Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
FDA Drug Recalls
17,898 recalls, newest first
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class II · Moderate risk Terminated
Tirosint - Sol
Reason Subpotent Drug
Class III · Low risk Ongoing
Atropine Sulfate Ophthalmic Solution
Reason Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Class II · Moderate risk Terminated
Verapamil Hydrochloride Extended-Release Tablets
Reason Failed Dissolution Specification: Out of specification dissolution results at time point zero. The OOS was above specified values.
Class III · Low risk Terminated
Clobetasol propionate Cream USP
Reason Subpotent Drug: Low assay result observed during long-term stability testing.
Class II · Moderate risk Terminated
Ohm Sanitizer Spray
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Terminated
Ohm Hand Sanitizer
Reason CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Class II · Moderate risk Ongoing
Hand Sanitizer
Reason CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Class II · Moderate risk Ongoing
Hand Sanitizer
Reason CGMP Deviations: Voluntary recall of all hand sanitizer distributed after March 31, 2022, due to FDA issued guidance to cease placing hand sanitizer product, produced under temporary approval, into the market after March 31, 2022.
Class II · Moderate risk Terminated
Allopurinol Tablets 100mg
Reason Presence of Foreign Substance: manufacturer recalled this re-packaged product due to reports of a small piece of green plastic embedded in the crack towards the edge of the tablet.
Class II · Moderate risk Terminated
Diltiazem Hydrochloride Extended-Release Capsules
Reason Failed Impurity (Deacetyl Diltiazem Hydrochloride) specification during stability testing and failed dissolution testing at FDA laboratory.
Class II · Moderate risk Terminated
S2 Racepinephrine Inhalation Solution
Reason Short Fill