Agency classClass IIOur severity:High FDA (Drugs)·D-0350-2024·Announced 2024-03-06

Mesalamine extended-release capsules recalled due to dissolution failure

Sun Pharmaceutical is recalling Mesalamine extended-release capsules due to failed dissolution specifications. The affected capsules may not dissolve and release medication properly.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The dissolution failure creates a risk of harm—medication ineffectiveness—but no adverse events have been reported. Therefore, the hazard is theoretical without reported injury, placing it at severity level 3 per the rubric.

Plain-English summary

Sun Pharmaceutical Industries Inc. is recalling Mesalamine extended-release capsules, USP 500mg, due to failed dissolution specifications. Approximately 54,960 bottles were distributed nationwide in the United States.

In pharmaceuticals, dissolution refers to how a medication dissolves and releases in the body. The recalled capsules failed to meet the specified dissolution requirements.

The affected product can be identified by NDC number 63304-089-13. Specific lot numbers with expiration dates ranging from April 2024 to September 2024 are included in this recall. The manufacturer has provided detailed lot number information to pharmacies and healthcare providers.

Patients using the recalled product should contact their healthcare provider or pharmacist. Do not stop medication without speaking to your healthcare professional. Return the recalled product to your pharmacy for a replacement.

The recalled product

Product: MESALAMINE (MESALAMINE)
Brand: MESALAMINE
Manufacturer: SUN PHARMACEUTICAL INDUSTRIES INC
Category: Drug — Gastrointestinal
Hazard: dissolution-failure
Affected units: 54,960

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

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

UPCs (1)

0363304089134

Distribution

Distributed nationwide across the United States.

Same brand · MESALAMINE

Moderate
Mesalamine Tablets Recalled for Manufacturing Equipment Microbial Contamination
FDA (Drugs) · 2024-01-31
Moderate
Teva Recalls Mesalamine Tablets Due to Failed Dissolution Testing
FDA (Drugs) · 2020-11-18
Moderate
Teva Recalls Mesalamine Tablets Due to Dissolution Test Failures
FDA (Drugs) · 2020-03-11

Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC

See all →

Low
Sun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
Low
Sun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Failures
FDA (Drugs) · 2026-10-14
Low
Sun Pharmaceutical Recalls Tretinoin Cream Due to Impurity Specifications
FDA (Drugs) · 2026-10-14
High
Sun Pharmaceutical Recalls Carbamazepine Tablets Due to Manufacturing Deviations
FDA (Drugs) · 2026-08-26
Low
Fexofenadine Hydrochloride Tablets 180 mg Recalled for Impurities
FDA (Drugs) · 2026-07-08

Same hazard · dissolution failure