Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Ongoing Initiated May 11, 2026 (5 months ago)

Gas-X

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

Cause type: Labeling / mix-up

Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.

What was recalled

Gas-X, Simethicone 125 mg/ ANTIGAS, 120 SoftGels, Distributed by: Haleon, Warren, NJ 07059, UPC: 3 00674 35041 9.

Recalling firm
Haleon US Holdings LLC
Origin
NJ, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0542-2026 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.

Other recalls by Haleon US Holdings LLC

All 2026 recalls
Class I · High risk

Gas-X Extra Strength

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

Ongoing Chemical / undeclared Haleon US Holdings LLC D-0595-2026
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 labeling / mix-up recalls from 2026

All labeling / mix-up recalls
Unclassified

0.9% Sodium Chloride Injection

Product Mix-up: 0.9% SODIUM CHLORIDE Injection, USP may potentially contain the overwrap with labeling indicating it to be 0.9% SODIUM CHLORIDE Injection, USP but the actual product within the overwrap may be POTASSIUM CHLORIDE Inj.10 mEq

Ongoing Labeling / mix-up Otsuka ICU Medical LLC NDC 0990-7984-23 Recall number pending
Class II · Moderate risk

fentaNYL Citrate

Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).

Ongoing Labeling / mix-up OurPharma LLC NDC 73013-1013-01 D-0864-2026
Class I · High risk

Morphine Sulfate Injection

Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.

Ongoing Labeling / mix-up Fresenius Kabi USA, LLC D-0788-2026