FDA Drug recall D-0542-2026
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9
- FDA Drug
- Class II
- ongoing
- Published 2026-05-27
On 2026-05-27 the FDA classified a Class II recall of Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9 by Haleon Us Holdings, citing labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0542-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-05-11 |
| Published | 2026-05-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Haleon Us Holdings |
| Distribution | US |
Product
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.
Identifiers
| upc | 300674350419 |
|---|---|
| code_info | Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0542-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.