Why it was recalled
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Product description
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Lot numbers, UPCs & expiration codes
Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
Where it was sold
U.S. Nationwide.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0542-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- May 11, 2026
- FDA report date
- May 27, 2026
- Quantity
- 285,330 blister cards
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Haleon US Holdings LLC
Original FDA data
Every field from FDA enforcement report D-0542-2026, exactly as published.
Show all FDA fields
- City
- Warren
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 98910
- Address
- 184 Liberty Corner Rd Ste 200
- Code information
- Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
- Postal code
- 07059-6870
- Report date
- May 27, 2026
- Product type
- Drugs
- Recall number
- D-0542-2026
- Classification
- Class II
- Recalling firm
- Haleon US Holdings LLC
- Product quantity
- 285,330 blister cards
- Reason for recall
- Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
- Distribution pattern
- U.S. Nationwide.
- Recall initiation date
- May 11, 2026
- Initial firm notification
- Letter
- Center classification date
- May 19, 2026