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Class II · ModerateActive recall

Mesalamine

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #s: MHD0606A, MHD0612A, Exp. 04/30/2024; MHD0613A, MHD0652A, MHD0657A, MHD0672A, MHD0673A, Exp. 05/31/2024; MHD0767A, MHD0768A, MHD0769A, MHD0785A, MHD0799A, MHD0800A, MHD0801A, Exp. 06/30/2024; MHD0827A, MHD0828A, MHD0875A, MHD0876A, MHD0898A, MHD0901A, Exp. 07/31/2024; MHD1081A, MHD1082A, MHD1087A Exp. 09/30/2024.
Where it was soldNationwide in the U.S.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Failed Dissolution Specifications: Out of specification for dissolution.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made bySun Pharmaceutical Industries Limited, Mohali, INDIA, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512 foreign manufacturer
Brand nameMESALAMINE
Generic nameMESALAMINE
Active ingredient(s)MESALAMINE
Distributed by / forSun Pharmaceutical Industries, Inc., Cranbury, NJ 08512
NDC63304-089-13
Show the full FDA record
Full product labelMesalamine 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.
Recalling firmSUN PHARMACEUTICAL INDUSTRIES INC
DistributionNationwide in the U.S.
Quantity54,960 bottles
Recall initiated2024-02-05
Report date2024-03-06
Recall completed—
Recall numberD-0350-2024
ClassificationClass II
FDA statusOngoing
Origin on filePrinceton NJ United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.