Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
FDA Drug Recalls
2,277 recalls · Class II, newest first
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets USP
Reason Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk Ongoing
Umary Acid Hyaluronic
Reason cGMP Deviations: the firm initiated a recall after notification from the distributor that product may be tainted with undeclared diclofenac and omeprazole, however there is no analytical data confirming that product distributed by the firm is tainted.
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Duloxetine Delayed-Release Capsules
Reason CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Class II · Moderate risk Ongoing
Kissable Diabetics Foot Cream
Reason CGMP Deviations: lack of adequate release testing.
Class II · Moderate risk Ongoing
Venofer
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk Ongoing
Venofer
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk Ongoing
Venofer
Reason Presence of Particulate Matter: Potential for glass delamination from the vials.
Class II · Moderate risk Ongoing
Docusate Sodium 250 mg
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Calcium Carbonate Chewable 500 mg
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Aspirin Chewable tablet 81 mg
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Vitamin B1
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Vitamin D3
Reason cGMP Deviations: Observations were made that some blister card-foils were separating from the blister cavity.
Class II · Moderate risk Ongoing
Levothyroxine Sodium Tablets
Reason Subpotent drug