Ulcerative Colitis Drug Recalled

Sun Pharmaceuticals Inc. is recalling nearly 55,000 bottles of mesalamine extended-release capsules after samples failed to meet dissolution specifications during routine testing, according to the March 6, 2024, US Food and Drug Administration (FDA) Enforcement Report.

The recall affects mesalamine extended-release capsules, 500 mg, in 120-count bottles (NDC 63304-089-13), from lots MHD0606A and MHD0612A (Exp. 4/30/24); MHD0613A, MHD0652A, MHD0657A, MHD0672A, and MHD0673A (Exp. 5/31/24); MHD0767A, MHD0768A, MHD0769A, MHD0785A, MHD0799A, MHD0800A, and MHD0801A (Exp. 6/30/24); MHD0827A, MHD0828A, MHD0875A, MHD0876A, MHD0898A, and MHD0901A (Exp. 7/31/24); and MHD1081A, MHD1082A, and MHD1087A (Exp. 9/30/24).

The recalled products were manufactured by Sun Pharmaceutical Industries Limited, Mohali, India, and distributed throughout the United States by Sun Pharmaceutical Industries Inc., Cranbury, New Jersey. 

Sun Pharmaceutical Industries voluntarily initiated the recall February 5, 2024. The FDA designated the recall Class II on February 23, 2024. Per the classification, use of the drug could cause temporary or medically reversible adverse health consequences or a remote possibility of serious harm.

Mesalamine is a prescription medication indicated for the induction of remission and the treatment of adults with mildly to moderately active ulcerative colitis.