⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a
very recent recall may be missing. Everything shown is accurate as of the last checked time on this page —
for anything time-critical, confirm with the official sources linked below.
FDAClass II · Drug · Recalled May 27, 2026
Gas-X recall — Haleon US Holdings LLC
Hazard: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- D-0542-2026
- Brand
- Haleon US Holdings
- Classification
- Class II
- Units affected
- 285,330 blister cards
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Affected products
Companies & origin
- Recalling firm location
- Warren, NJ, United States
- Firm address
- 184 Liberty Corner Rd Ste 200, 07059-6870
Identifying details (verbatim from the notice)
- Product codes / lots
- Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
- Distribution
- U.S. Nationwide.
- Firm notified the public via
- Letter
- FDA event ID
- 98910
- Recall initiated
- May 11, 2026
- FDA classified
- May 19, 2026
- FDA report date
- May 27, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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