Gas-X Simethicone 125 mg softgels recall for incomplete labeling
Haleon is recalling Gas-X Simethicone 125 mg softgels due to incomplete inactive ingredient information on carton labeling.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II labeling recall involving incomplete inactive ingredient information, a minor labeling deficiency. No illness, injury, or known harm is reported in the source text.
Plain-English summary
Haleon US Holdings LLC is recalling Gas-X Simethicone 125 mg/Antigas 120 softgels distributed nationwide due to incomplete inactive ingredient information on the carton labeling.
The affected product lots are KB5Y (expires 04/2028), MP4B (expires 05/2028), and SS4F (expires 09/2028). The product is identified by UPC 3 00674 35041 9.
Consumers with affected packages should discontinue use. Healthcare providers or consumers with questions can contact Haleon.
The recalled product
- Product
- Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
- Manufacturer
- Haleon US Holdings LLC
- Category
- Drug — Over-the-counter
- Hazard
- labeling-error
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lot: KB5Y
- Expires: 04/2028
- MP4B
- Expires: 05/2028
- SS4F
- Expires: 09/2028.
Distribution
Distributed nationwide across the United States.