FDA Drugs recall ·
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0595-2026
- Date
- (initiated June 4, 2026)
- Company / brand
- Haleon US Holdings LLC
184 Liberty Corner Rd Ste 200, Warren, NJ, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 35,883 boxes/carton
- Hazard tags
- Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
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
Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
Distribution
Nationwide within the United States
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0595-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.