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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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
- Affected units
- 285,330
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.
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