Quick Facts at a Glance
- Recall Date
- May 11, 2026
- Hazard Level
- HIGH
- Brand
- Haleon US Holdings
- Geographic Scope
- 1 states
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Haleon US Holdings
- Model numbers
- Lot: KB5Y, Expires: 04/2028, MP4B, Expires: 05/2028, SS4F, Expires: 09/2028.
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
May 11, 2026
Reported by FDA DRUG
May 27, 2026
RecallRadar source check
June 3, 2026
Consumer action
Use the official remedy and keep documentation.
Hazard Information
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
What You Should Do
Consumers and healthcare providers should stop using this product immediately. Contact Haleon US Holdings LLC or your healthcare provider for guidance. Notification method: Letter
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Full Description
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.. Reason: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.. Classification: Class II. Quantity: 285,330 blister cards. Distribution: U.S. Nationwide.
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Safety Guide
Not sure what to do next? Our guide walks you through the process step by step.
Read: How to Get Refunds and ReplacementsWant to Know First?
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