Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Mesalamine Extended-Release Capsules Recalled by SUN PHARMACEUTICAL INDUSTRIES INC Due to Failed Dissolution Specifications: Out of specification for dissolution.
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact SUN PHARMACEUTICAL INDUSTRIES INC directly.
Affected Products
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.
Quantity: 54,960 bottles
Why Was This Recalled?
Failed Dissolution Specifications: Out of specification for dissolution.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About SUN PHARMACEUTICAL INDUSTRIES INC
SUN PHARMACEUTICAL INDUSTRIES INC has 86 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report