# FDA recall D-0350-2024

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2024-02-05.

## 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.

## Reason for recall

Failed Dissolution Specifications: Out of specification for dissolution.

## Distribution

Nationwide in the U.S.

## Key facts

- **Recall number:** D-0350-2024
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2024-02-05
- **Report date:** 2024-03-06

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Princeton, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0350-2024

## Citation

> MORVS. FDA recall D-0350-2024. Retrieved 2026-10-16 from https://api.morvs.ai/recall/D-0350-2024. Source: US FDA. Licensed CC0.

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