D-0542-2026 Class II Ongoing
FDA drug recall D-0542-2026 was initiated by Haleon US Holdings LLC on May 11, 2026 and is designated Class II. Reason for recall: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. The recall status is ongoing. Affected quantity: 285,330 blister cards.
Recall Details
- Product Type
- Drugs
- Report Date
- May 27, 2026
- Initiation Date
- May 11, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 285,330 blister cards
Product Description
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Reason for Recall
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Distribution Pattern
U.S. Nationwide.
Code Information
Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.