FDA DrugsClass I
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (U...
Published: June 17, 2026Recall ID: D-0595-2026Category: drugsCountry: US
Reason for Recall / Hazard
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Product Description & Identification
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.
Additional Source Details
| Field | Value |
|---|---|
| City | Warren |
| State | NJ |
| Event id | 99125 |
| Address 1 | 184 Liberty Corner Rd Ste 200 |
| Address 2 | N/A |
| Code info | Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028. |
| Postal code | 07059-6870 |
| Report date | 20260617 |
| Product type | Drugs |
| Product quantity | 35,883 boxes/carton |
| Reason for recall | Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. |
| Voluntary mandated | Voluntary: Firm initiated |
| Recall initiation date | 20260604 |
| Initial firm notification | Press Release |
| Center classification date | 20260617 |
Overview
- Recalling FirmHaleon US Holdings LLC
- StatusOngoing
- Risk LevelClass I
- DistributionNationwide within the United States