Haleon US Holdings LLC Gas-X Extra Strength, Simethicone 125 mg/Antigas recall: Chemical Contamination: contamination with a diluted propylene glycol-based
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
The hazard: Drug safety concern
The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.
What the notice says: Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
Why it matters: The FDA recorded an enforcement action against this product. The classification and the summary above describe how serious the agency considers it.
Recall details
- Recall number
- D-0595-2026
- Published
- June 17, 2026
- Risk level
- Class I
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Haleon US Holdings LLC
- Product type
- Prescription & OTC drugs
- Units affected
- 35,883 boxes/carton
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Lots: a) TL8K, YH9X, YH9Y, Exp. Date. 30Nov2028; b) X78N, Exp. Date 30Nov2028.
- UPC codes
- 300674350419, 300439005721
Products covered by this recall
Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels (UPC 3 00674 35041 9, b) 72 SoftGels (UPC 3 00439 00572 1), Distributed by: Haleon, Warren, NJ 07059.
Check your product
The notice names 5 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.
UPC / barcode
Read the twelve digits under the barcode on the package.
- 300674350419
- 300439005721
Best-by / use-by date
Printed beside the lot code, not on the price sticker.
- 30Nov2028. — 35
- 883 boxes
Package size
Match the net weight or the piece count on the front of the pack.
- 125 mg
Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.
What to do about Drug safety
Haleon US Holdings LLC — The product was withdrawn from distribution. Whether your own pack is affected comes down to the lot number.
- Check the lot number on your pack against the codes listed above.
- Keep the carton; the lot number is often printed only on the outer pack.
- Report side effects you think the product caused to FDA MedWatch.
- Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
What the company owes you
A recalled medicine is the manufacturer’s cost to carry, not yours or your pharmacist’s.
- The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
- Ask the pharmacy to handle the claim where they can — they process recall returns in bulk and it saves you the correspondence.
- Keep the carton, the leaflet and the pharmacy label together until the claim is closed.
- Costs beyond the price of the medicine need to go to the company directly, in writing, with the recall number quoted.
Company contact: Haleon US Holdings LLC — 184 Liberty Corner Rd Ste 200, Warren, NJ, 07059-6870
The official notice
This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.
Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls
Questions people ask about this recall
Why was Haleon US Holdings LLC prescription & otc drugs recalled?
Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process. Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 300674350419, 300439005721; best-by date 30Nov2028. — 35 or 883 boxes. If the code on your package is not on that list, your unit is outside the recall.
What should I do with it right now?
Check the lot number on your pack against the codes listed above.
Can I get my money back?
The purchase price or co-pay is refundable, and so is the cost of returning the product if they ask you to ship it.
Where was the recalled product sold?
It was distributed nationwide.
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