# FDA recall D-0542-2026

> **Haleon US Holdings LLC** · Class II · drug recall initiated 2026-05-11.

## Product

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.

## Reason for recall

Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

## Distribution

U.S. Nationwide.

## Key facts

- **Recall number:** D-0542-2026
- **Recalling firm:** Haleon US Holdings LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-05-11
- **Report date:** 2026-05-27

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0542-2026

## Citation

> MORVS. FDA recall D-0542-2026. Retrieved 2026-10-22 from https://api.morvs.ai/recall/D-0542-2026. Source: US FDA. Licensed CC0.

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