Class I · Most seriousActive recall
Gas-X Extra Strength
A reasonable chance it could cause serious harm or death.
Does this affect you?
Check your lot numberLots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
Where it was soldNationwide within the United States
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
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
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 |
Show the full FDA record
| Full product label | Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059. |
| Recalling firm | Haleon US Holdings LLC |
| Distribution | Nationwide within the United States |
| Quantity | 35,883 boxes/carton |
| Recall initiated | 2026-06-04 |
| Report date | 2026-06-17 |
| Recall completed | — |
| Recall number | D-0595-2026 |
| Classification | Class I |
| 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.