Medications & Supplements/Prescription Drugs

Mesalamine Extended-Release Capsules Recalled for Failed Dissolution

Agency Publication Date: February 23, 2024

Summary

Sun Pharmaceutical Industries is recalling Mesalamine Extended-Release Capsules, USP 500mg (generic Lialda/Asacol), because they failed dissolution testing. Approximately 54,960 bottles are affected by this recall as the medication may not release properly in the body. This prescription drug is used to treat inflammatory bowel conditions, and if it fails to dissolve correctly, it may not be effective in treating the patient's symptoms.

Risk

The medication was found to be out of specification for dissolution, meaning the capsules may not break down and release the active ingredient at the required rate. This can lead to a lack of therapeutic effect, potentially causing the patient's condition to remain untreated or worsen.

What You Should Do

This recall affects 120-count bottles of Mesalamine Extended-Release Capsules, USP 500mg, under NDC 63304-089-13.
Identify the product by checking the bottle for the NDC code 63304-089-13 and looking for the lot number and expiration date printed on the label. Affected lot numbers include MHD0606A, MHD0612A, MHD0613A, and many others through expiration dates in September 2024. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Mesalamine Extended-Release Capsules, USP 500mg (120 Capsules per bottle)

Variants: 500mg

Lot Numbers:

MHD0606A (Exp. 04/30/2024)

MHD0612A (Exp. 04/30/2024)

MHD0613A (Exp. 05/31/2024)

MHD0652A (Exp. 05/31/2024)

MHD0657A (Exp. 05/31/2024)

MHD0672A (Exp. 05/31/2024)

MHD0673A (Exp. 05/31/2024)

MHD0767A (Exp. 06/30/2024)

MHD0768A (Exp. 06/30/2024)

MHD0769A (Exp. 06/30/2024)

MHD0785A (Exp. 06/30/2024)

MHD0799A (Exp. 06/30/2024)

MHD0800A (Exp. 06/30/2024)

MHD0801A (Exp. 06/30/2024)

MHD0827A (Exp. 07/31/2024)

MHD0828A (Exp. 07/31/2024)

MHD0875A (Exp. 07/31/2024)

MHD0876A (Exp. 07/31/2024)

MHD0898A (Exp. 07/31/2024)

MHD0901A (Exp. 07/31/2024)

MHD1081A (Exp. 09/30/2024)

MHD1082A (Exp. 09/30/2024)

MHD1087A (Exp. 09/30/2024)

NDC:

63304-089-13

Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 93909

Status: Active

Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC

Sold By: Retail Pharmacies

Manufactured In: India

Units Affected: 54,960 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects 120-count bottles of Mesalamine Extended-Release Capsules, USP 500mg, under NDC 63304-089-13.

Identify the product by checking the bottle for the NDC code 63304-089-13 and looking for the lot number and expiration date printed on the label. Affected lot numbers include MHD0606A, MHD0612A, MHD0613A, and many others through expiration dates in September 2024. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Sun Pharmaceutical Industries, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Mesalamine Extended-Release Capsules, USP 500mg (120 Capsules per bottle)

Variants: 500mg

Lot Numbers:

MHD0606A (Exp. 04/30/2024)

MHD0612A (Exp. 04/30/2024)

MHD0613A (Exp. 05/31/2024)

MHD0652A (Exp. 05/31/2024)

MHD0657A (Exp. 05/31/2024)

MHD0672A (Exp. 05/31/2024)

MHD0673A (Exp. 05/31/2024)

MHD0767A (Exp. 06/30/2024)

MHD0768A (Exp. 06/30/2024)

MHD0769A (Exp. 06/30/2024)

MHD0785A (Exp. 06/30/2024)

MHD0799A (Exp. 06/30/2024)

MHD0800A (Exp. 06/30/2024)

MHD0801A (Exp. 06/30/2024)

MHD0827A (Exp. 07/31/2024)

MHD0828A (Exp. 07/31/2024)

MHD0875A (Exp. 07/31/2024)

MHD0876A (Exp. 07/31/2024)

MHD0898A (Exp. 07/31/2024)

MHD0901A (Exp. 07/31/2024)

MHD1081A (Exp. 09/30/2024)

MHD1082A (Exp. 09/30/2024)

MHD1087A (Exp. 09/30/2024)

NDC:

63304-089-13

Manufactured by: Sun Pharmaceutical Industries Limited, Mohali, INDIA; Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512.