Where can I verify this recall directly with FDA?

The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.

What was recalled and why?

Haleon US Holdings LLC recalled Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.. FDA's record states the reason for recall as: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.. The recall is logged under FDA recall number D-0542-2026 with a Class II classification.

What should someone who has this product do?

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.) and recall number D-0542-2026, then follow Haleon US Holdings LLC's recall instructions.

Recall Record: Class II Recall: Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed… by Haleon US Holdings LLC

Here's the summary: Haleon US Holdings LLC recalled Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9. on 2026-05-27. FDA classified this action as a Class II recall (recall number D-0542-2026). Reason for recall: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.. Recall status: Ongoing. This is a drug-category FDA recall record. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Key facts

Recalling firm	Haleon US Holdings LLC
Manufacturer	Not disclosed in the FDA record.
Brand name	Not disclosed in the FDA record.
Product description	Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Classification	Class II
Recall number	D-0542-2026
Report date	Not disclosed in the FDA record.
Status	Ongoing
Reason for recall	Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

What this classification means

FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote. In this case, the recalling firm is Haleon US Holdings LLC and the affected product is described in FDA's record as: Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.. FDA's stated reason for the recall is: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.. The recall is tracked under FDA recall number D-0542-2026 and carries a status of Ongoing as of the most recent FDA enforcement report. This classification reflects FDA's assessment of the product defect described above, not a prediction about any specific patient outcome. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do. Recall status can change while FDA and the recalling firm continue corrective actions, so checking the firm's own notice for the most current guidance is recommended. Adverse events believed to be related to a recalled product can be reported to FDA's MedWatch program, which FDA uses to monitor safety signals after a recall is opened.

What consumers should do

Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Specifically, check whether the product in your possession matches the description on file with FDA -- Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9. -- and the recall number D-0542-2026. If it matches, stop using or distributing it and contact Haleon US Holdings LLC or the point of purchase for return or replacement instructions. Retailers and distributors holding affected inventory should quarantine it and follow the firm's written recall notice. FDA maintains a public enforcement report database so that consumers, physicians, and purchasers can look up the exact product identifiers involved before deciding what to do.

Haleon US Holdings LLC’s FDA history

Argus HQ has recorded 2 total FDA actions tied to Haleon US Holdings LLC: 0 warning letters, 2 recalls, 0 approval records, and 0 Form 483 inspection citations.

Frequently asked questions

Where can I verify this recall directly with FDA?: The verbatim FDA record is the source of truth for every recall Argus HQ tracks — always confirm against fda.gov before acting.
What was recalled and why?: Haleon US Holdings LLC recalled Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.. FDA's record states the reason for recall as: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.. The recall is logged under FDA recall number D-0542-2026 with a Class II classification.
How serious is this recall?: FDA classifies a recall as Class II when using the recalled product, or being exposed to it, may cause temporary or medically reversible adverse health consequences, or when the probability of serious adverse health consequences is remote.
What should someone who has this product do?: Because this recall carries FDA's middle severity classification, anyone who has this product should stop using it and follow the recalling firm's instructions, even though serious harm is considered unlikely for this classification. Check the product against FDA's description (Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.) and recall number D-0542-2026, then follow Haleon US Holdings LLC's recall instructions.

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Full FDA history for Haleon US Holdings LLC

Compiled by Argus HQ Research from FDA primary sources · Reviewed by Andy Gaber, Founder

Cite this record

Reusing this data in reporting or research? Here’s a ready-made citation.

APA

Argus HQ Research (2026). Recall Record: Class II Recall: Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed… by Haleon US Holdings LLC. Digital Empire LLC. Retrieved from https://argushq.ai/recall/fda-recall-haleon-us-holdings-llc-d-0542-2026

MLA

"Recall Record: Class II Recall: Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed… by Haleon US Holdings LLC." Argus HQ Research, Digital Empire LLC, 2026, argushq.ai/recall/fda-recall-haleon-us-holdings-llc-d-0542-2026.

Chicago

Argus HQ Research. "Recall Record: Class II Recall: Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed… by Haleon US Holdings LLC." Digital Empire LLC. Accessed July 13, 2026. https://argushq.ai/recall/fda-recall-haleon-us-holdings-llc-d-0542-2026.

BibTeX

@misc{argushq_argushq_ai_recall_fda_recall_haleon_us_holdings_llc_d_0542_2026_2026,
  title = {Recall Record: Class II Recall: Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed… by Haleon US Holdings LLC},
  author = {{Argus HQ Research}},
  year = {2026},
  publisher = {Digital Empire LLC},
  url = {https://argushq.ai/recall/fda-recall-haleon-us-holdings-llc-d-0542-2026},
  note = {Accessed: July 13, 2026}
}

Source: FDA.gov — Recalls ↗