Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class I · High risk Ongoing Initiated Jun 4, 2026 (4 months ago)

Gas-X Extra Strength

Class I — High risk. Reasonable probability of serious harm or death.

Why it was recalled

Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machine leakage during the packaging process.

Cause type: Chemical / undeclared

A chemical that should not be there - benzene, methanol, lead - or an undeclared prescription drug hidden in a supplement. The label gives no warning: you may be taking a toxic solvent, a heavy metal, or a drug such as sildenafil that interacts with your other medicines. All chemical / undeclared recalls.

What was recalled

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.

Recalling firm
Haleon US Holdings LLC
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
Company announcement
Jun 4, 2026 · FDA notice with lot numbers
FDA recall number
D-0595-2026 · FDA notice

Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week.

Other recalls by Haleon US Holdings LLC

All 2026 recalls
Class II · Moderate risk

Gas-X

Labeling: Not Elsewhere Classified- Incomplete inactive ingredient information on the carton labeling.

Ongoing Labeling / mix-up Haleon US Holdings LLC D-0542-2026
Class III · Low risk

parodontax

Labeling: Incorrect or Missing Lot and/or Exp Date: Potential for missing or illegible lot and expiration date coding on the bottles.

Ongoing Labeling / mix-up Haleon US Holdings LLC NDC 0135-0651-02 D-0297-2026
Class III · Low risk

Sensodyne PRONAMEL

Labeling: Label Mix-up: The outer carton is labelled Fresh Mint. The tube is labelled Cool Mint/Whitening. The toothpaste inside the tube is Fresh Mint as indicated on the outer carton

Ongoing Labeling / mix-up Haleon US Holdings LLC D-0592-2025

Other chemical / undeclared recalls from 2026

All chemical / undeclared recalls
Class II · Moderate risk

Naproxen Oral Suspension

Chemical contamination; presence of lead and lithium above specification

Ongoing Chemical / undeclared Acella Pharmaceuticals, LLC NDC 42192-619-16 D-0523-2026
Class I · High risk

Kian Pee Wan Capsules

Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.

Ongoing Chemical / undeclared Buy-Herbal D-0769-2026