Haleon US Holdings LLC Gas-X, Simethicone 125 mg/ Antigas, 120 SoftGels recall: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
The hazard: Drug safety concern
A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.
What the notice says: Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
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-0542-2026
- Published
- May 27, 2026
- Risk level
- Class II
- Status
- Ongoing
- Issued by
- U.S. Food and Drug Administration
- Brand
- Haleon US Holdings LLC
- Product type
- Prescription & OTC drugs
- Units affected
- 285,330 blister cards
- Distribution
- Nationwide
- Made in
- United States
- Lot / code info
- Lot: KB5Y, Expires: 04/2028; MP4B, Expires: 05/2028; SS4F, Expires: 09/2028.
- UPC codes
- 300674350419
Products covered by this recall
Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.
Check your product
The notice names 9 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
Lot or batch code
Usually ink-stamped near the seam, the cap or the bottom of the pack.
- KB5Y
Best-by / use-by date
Printed beside the lot code, not on the price sticker.
- 04
- 2028
- 05
- 09
- 2028. — 285
- 330 blister cards
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 — A problem with this medicine prompted the recall. With prescriptions, the first move is a conversation rather than a decision.
- Check the lot number on your pack against the codes listed above.
- Do not stop a prescribed medicine on your own — speak to your prescriber or pharmacist first.
- Ask the dispensing pharmacy for a replacement from an unaffected lot.
- Keep the carton; the lot number is often printed only on the outer pack.
Getting a replacement supply
Do not let a refund question interrupt your treatment. Deal with the supply first and the money second.
- Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
- Insurers do not normally count a recall replacement against a refill limit. If one is refused, ask the pharmacist to call it through as a recall override.
- Over-the-counter products are refunded at the till like any other purchase; the recall notice on your phone is enough to explain the return.
- If the manufacturer runs a direct reimbursement form, it will be linked from the official notice on this page.
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?
Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling. Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.
How do I know if I have the recalled product?
Match the codes printed on your package against the notice: UPC 300674350419; lot code KB5Y; best-by date 04 or 2028. 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?
Call the pharmacy before you run low. They can see which lot they dispensed to you and will usually swap it the same day.
Where was the recalled product sold?
It was distributed nationwide.
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