# FDA recall D-1543-2022

> **Novartis Pharmaceuticals Corporation** · Class II · drug recall initiated 2022-09-16.

## Product

Neoral soft gelatin capsules (cyclosporine capsules, USP) Modified, 25 mg, Rx Only, 30 Soft Gelatin Capsules per carton, Mfg by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936, NDC # 0078-0246-15.

## Reason for recall

CGMP deviations: Out of specification results obtained during routine stability testing for ethanol content.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-1543-2022
- **Recalling firm:** Novartis Pharmaceuticals Corporation
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-09-16
- **Report date:** 2022-10-05
- **Termination date:** 2024-03-11

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1543-2022

## Citation

> AI Analytics. FDA recall D-1543-2022. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-1543-2022. Source: US FDA. Licensed CC0.

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