Class I · High risk
Clonazepam Orally Disintegrating Tablet
Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister strips inside the product carton reflect the correct strength.
FDA drug recalls in 2024
Every FDA drug recall initiated in 2024, newest first, with its risk class, status and the reason the FDA recorded. Use the cause and risk filters to narrow the year down.
557 recalls, newest first.
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Levothyroxine Sodium Tablets USP
Superpotent Drug and Subpotent Drug: potency failures obtained
Class II · Moderate risk
Lisinopril Tablets
Presence of Foreign Object: A pharmacist discovered a metal fragment embedded in a lisinopril 10 mg tablet.
Class II · Moderate risk
Umary Acid Hyaluronic
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
Henry Schein
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II · Moderate risk
Ipana
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II · Moderate risk
Quala Dental Products
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II · Moderate risk
safco
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II · Moderate risk
Pearson Quality
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II · Moderate risk
Burkhart
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II · Moderate risk
Health-Tec
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II · Moderate risk
Patterson Dental
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II · Moderate risk
Dental City
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II · Moderate risk
Primo
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.
Class II · Moderate risk
M&S Dental Supply Co LLC.
CGMP deviations: the bulk product was rejected by the Quality Unit after routine inspection of the mixing vessel showed scratches on the sides and bottom of the mixing vessel. Product was to be rejected but was inadvertently released and shipped to customers.