D-0595-2026 Class I Ongoing
FDA drug recall D-0595-2026 was initiated by Haleon US Holdings LLC on June 4, 2026 and is designated Class I. Reason for recall: Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. The recall status is ongoing. Affected quantity: 35,883 boxes/carton.
Recall Details
- Product Type
- Drugs
- Report Date
- June 17, 2026
- Initiation Date
- June 4, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 35,883 boxes/carton
Product Description
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 for Recall
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Distribution Pattern
Nationwide within the United States
Code Information
Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.