Haleon US Holdings LLC: 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), Di
Read the official notice at FDA (drug) →
Get alerts for Haleon US Holdings
The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.
- Company / brand
- Haleon US Holdings LLC
- 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.
- Reason / hazard
- Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
- Classification
- Class I
- Status
- Ongoing
- Distribution / sold at
- Nationwide within the United States
- Recall initiated
- 2026-06-04
- Code info
- Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
- Product quantity
- 35,883 boxes/carton
- Voluntary mandated
- Voluntary: Firm initiated
- City
- Warren
- State
- NJ
- Country
- United States
- Event id
- 99125
Free daily digest + "My products" watchlist