Class II · ModerateActive recall
Gas-X
Could cause temporary or reversible harm; serious harm is unlikely.
Does this affect you?
Check your lot numberLot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
Where it was soldU.S. Nationwide.
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
| Distributed by / for | Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9 |
Show the full FDA record
| Full product label | Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9. |
| Recalling firm | Haleon US Holdings LLC |
| Distribution | U.S. Nationwide. |
| Quantity | 285,330 blister cards |
| Recall initiated | 2026-05-11 |
| Report date | 2026-05-27 |
| Recall completed | — |
| Recall number | D-0542-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Warren NJ United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.