Class II

Drug Recall: Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries,

SUN PHARMACEUTICAL INDUSTRIES INC · February 5, 2024

Reason for Recall

Failed Dissolution Specifications: Out of specification for dissolution.

Product Description

Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13.

Distribution

Nationwide in the U.S.

States Affected

NATIONWIDE

Quantity Affected

54,960 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0350-2024

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.