FDA Drugs recall ·
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon… recall
- Recall number
- D-0542-2026
- Date
- (initiated May 11, 2026)
- Company / brand
- Haleon US Holdings LLC
184 Liberty Corner Rd Ste 200, Warren, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 285,330 blister cards
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Why was it recalled?
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
Distribution
U.S. Nationwide.
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0542-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.