Mesalamine Extended-Release Capsules recall
FDA recall D-0350-2024 · initiated Feb 5, 2024
SUN PHARMACEUTICAL INDUSTRIES INC recalled Mesalamine Extended-Release Capsules in Feb 2024 — an FDA Class II recall (D-0350-2024) because Failed Dissolution Specifications: Out of specification for dissolution.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Failed Dissolution Specifications: Out of specification for dissolution.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 54,960 bottles
Details
- Product
- 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.
- Recalling company
- Sun Pharm Industries
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the U.S.
- Initiated
- Feb 5, 2024
- FDA report date
- Mar 6, 2024
Frequently asked
- Was Mesalamine Extended-Release Capsules recalled?
- SUN PHARMACEUTICAL INDUSTRIES INC recalled Mesalamine Extended-Release Capsules in Feb 2024 — an FDA Class II recall (D-0350-2024) because Failed Dissolution Specifications: Out of specification for dissolution. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Mesalamine Extended-Release Capsules recalled?
- Per the FDA enforcement record, the reason for recall D-0350-2024 was: Failed Dissolution Specifications: Out of specification for dissolution.
- Is a recalled Mesalamine Extended-Release Capsules dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Mesalamine Extended-Release Capsules are affected?
- Distributed: Nationwide in the U.S.. The recall covers these lots — Lot #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…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0350-2024.