Gas-X — Class II drug recall D-0542-2026
Ongoing recall by Haleon US Holdings LLC, reported 2026-05-27, distributed nationwide. Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
| Recall number | D-0542-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Haleon US Holdings LLC, Warren, NJ, United States |
| Recall initiated | 2026-05-11 |
| Classified | 2026-05-19 |
| Reported by FDA | 2026-05-27 |
| Distributed | Nationwide (US) |
| Quantity | 285,330 blister |
| Reason classes | labeling |
| UPC / GTIN / UDI-DI | 00300674350419 |
| Lot numbers | KB5Y, MP4B, SS4F |
| Expiration dates | 2028-04, 2028-05, 2028-09 |
Product
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0542-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.