# FDA recall D-0925-2023

> **Ascend Laboratories, LLC** · Class II · drug recall initiated 2023-07-11.

## Product

Fingolimod Capsules, 0.5 mg, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA; Distributed by: Ascend Laboratories, LLC, Parsippany, NJ  07054, NDC 67877-476-30.

## Reason for recall

Failed Dissolution Specifications

## Distribution

Nationwide in the USA

## Key facts

- **Recall number:** D-0925-2023
- **Recalling firm:** Ascend Laboratories, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2023-07-11
- **Report date:** 2023-07-26

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0925-2023

## Citation

> AI Analytics. FDA recall D-0925-2023. Retrieved 2026-06-25 from https://api.ai-analytics.org/recall/D-0925-2023. Source: US FDA. Licensed CC0.

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