Reported Mar 6, 2024 · Ongoing
Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle, Manufactured by: Sun Pharmaceutical…
Sun Pharmaceutical Industries Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: SUN PHARMACEUTICAL INDUSTRIES INC · 2 Independence Way · Princeton, NJ · 08540-6620
Is this the product you have?
- Mesalamine Extended-Release Capsules, USP 500mg, Rx Only, 120 Capsules per bottle
- Manufactured bySun Pharmaceutical Industries Limited, Mohali, INDIA
- Distributed bySun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 63304-089-13
- Lot codes and dates
5 of 5 products
Products covered by this recall # Product as published 1 MHD0606A, MHD0612A, Exp. 04/30/2024 2 MHD0613A, MHD0652A, MHD0657A, MHD0672A, MHD0673A, Exp. 05/31/2024 3 MHD0767A, MHD0768A, MHD0769A, MHD0785A, MHD0799A, MHD0800A, MHD0801A, Exp. 06/30/2024 4 MHD0827A, MHD0828A, MHD0875A, MHD0876A, MHD0898A, MHD0901A, Exp. 07/31/2024 5 MHD1081A, MHD1082A, MHD1087A Exp. 09/30/2024. - Amount recalled
- 54,960 bottles
Where it was sold
- Nationwide
Why it was recalled
Failed Dissolution Specifications: Out of specification for dissolution.
This product could cause temporary or reversible health problems — stop using it.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
Free recall alerts
Get alerted about new Sun Pharmaceutical Industries Inc. recalls
One email when a matching recall is published. No account, no cost, unsubscribe in one click.
We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.