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CLASS II · ModerateFDA

Haleon US Holdings LLC recalls Gas-X

📅 May 11, 2026 · 📍 Nationwide
Recalling company
Haleon US Holdings LLC
Product
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Reason
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
May 11, 2026
Reported
May 27, 2026
Distribution
U.S. Nationwide.
Status
Ongoing
Quantity
285,330 blister cards
Lot / codes
Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
Company location
Warren, NJ
Recall type
Voluntary: Firm initiated
Recall number
D-0542-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0542-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.