# FDA recall D-0147-2026

> **SUN PHARMACEUTICAL INDUSTRIES INC** · Class II · drug recall initiated 2025-10-28.

## Product

Lisdexamfetamine Dimesylate Capsules, 40 mg, CII, 100-count bottle, Rx only, Manufactured by: OHM Laboratories, New Brunswick, NJ 08901, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 57664-049-88.

## Reason for recall

Failed Dissolution Specifications: An out of specification results observed in dissolution test during analysis at 12-month long term stability station (25¿C, 60%RH) for Lisdexamfetamine dimesylate capsules.

## Distribution

U.S Nationwide.

## Key facts

- **Recall number:** D-0147-2026
- **Recalling firm:** SUN PHARMACEUTICAL INDUSTRIES INC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-10-28
- **Report date:** 2025-11-05

- **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-0147-2026

## Citation

> AI Analytics. FDA recall D-0147-2026. Retrieved 2026-06-08 from https://api.ai-analytics.org/recall/D-0147-2026. Source: US FDA. Licensed CC0.

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