FDA DrugsClass II
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren...
Published: May 27, 2026Recall ID: D-0542-2026Category: drugsCountry: US
Reason for Recall / Hazard
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Product Description & Identification
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Additional Source Details
| Field | Value |
|---|---|
| City | Warren |
| State | NJ |
| Event id | 98910 |
| Address 1 | 184 Liberty Corner Rd Ste 200 |
| Code info | Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028. |
| Postal code | 07059-6870 |
| Report date | 20260527 |
| Product type | Drugs |
| 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 |
| Recall initiation date | 20260511 |
| Initial firm notification | Letter |
| Center classification date | 20260519 |
Overview
- Recalling FirmHaleon US Holdings LLC
- StatusOngoing
- Risk LevelClass II
- DistributionU.S. Nationwide.