Subpotent Ointment Recalled

More than 2 million tubes of mupirocin ointment distributed by Glenmark Pharmaceuticals are under recall for subpotency, according to the October 2, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects mupirocin ointment, 2%, in 22-gram tubes (NDC 68462-180-22) from the following lots:

• 19223615, 19223537, 19223544, 19223568, 19223593, and 19223641 (Exp. 8/24); 
• 19224055, 19224281, 19224307, 19224321, 19224341, and 19224467 (Exp. 9/24); 
• 19224525, 19224542, 19224560, and 19224580 (Exp. 10/24); 
• 19224990, 19224998, 19225014, 19225033, 19225293, 19225304, 19225320, 19225349, 19225367, 19225379, and 19225401 (Exp. 11/24); 
• 19230115, 19230123, 19230132, 19230137, 19230167, and 19230170 (Exp. 12/24); 
• 19230572, 19230607, 19230614, 19230628, and 19230631 (Exp. 1/25); and 
• 19230874, 19230925, 19230941, 19230957, 19230976, 19231232, 19231238, 19231282, and 19231285 (Exp. 2/25).

The ointment was manufactured by Glenmark Pharmaceuticals Ltd., Goa, India, for Glenmark Pharmaceuticals Inc. USA, Mahwah, New Jersey, and was distributed throughout the United States.

Glenmark Pharmaceuticals Inc. USA voluntarily initiated the recall on August 30, 2024. On September 20, 2024, the FDA designated the recall Class II. Per the recall classification, use of the drug could cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Mupirocin is an antibacterial ointment available with a prescription for the topical treatment of impetigo due to susceptible isolates of Staphylococcus aureus and Streptococcus pyogenes.