Recall Summary
| Recall number | D-0595-2026 |
| Issued by | U.S. Food and Drug Administration |
| Date | 2026-06-17 |
| Company | Haleon US Holdings LLC |
| Units affected | 35,883 |
| Severity | Class I |
Remedy: Follow the instructions in the official notice linked below. The agency record for this recall did not contain remedy text we could verify against this product, so we have not reproduced it here.
Read the official U.S. Food and Drug Administration recall notice
haleon us recall notices matter to anyone with a common stomach remedy at home. On June 17, 2026, the U.S. Food and Drug Administration recorded a recall of Gas-X Extra Strength SoftGels. The maker is Haleon US Holdings LLC. The reason is chemical contamination during packaging. This guide explains the recall in plain terms. It tells you what was affected, why it is serious, and what steps to take next.
What the Haleon Us Recall Covers
The haleon us recall covers Gas-X Extra Strength SoftGels. The active ingredient is simethicone at 125 mg per softgel. It is marketed as an antigas product. Many households keep it on hand for bloating and pressure. The recall focuses on specific package sizes, not every Gas-X item on the shelf.
Two package configurations are named in the record. The first is the 120 SoftGels size, carrying UPC 3 00674 35041 9. The second is the 72 SoftGels size, carrying UPC 3 00439 00572 1. Both were distributed by Haleon of Warren, New Jersey 07059. For example, checking the UPC on the box is the fastest way to confirm a match.
The recall scope is 35,883 units. That is the total number of packages covered by this action. The FDA assigned recall number D-0595-2026 to the event. Typically, a recall number helps you track the official record. As a result, you can match your product to the agency listing with confidence.
The agency record does not spell out every retail location or sale date. In most cases, nationally distributed drugs reach pharmacies, grocery chains, and big-box stores. However, this article will not guess where each unit sold. Rely on the UPC codes and the recall number above to identify affected stock.
The Hazard and Reported Injuries
The hazard in the haleon us recall is chemical contamination. The FDA describes contamination with a diluted propylene glycol-based coolant. That coolant reportedly entered the product from a machine leak during packaging. In short, a fluid that belongs inside equipment may have reached the softgels. This is why the agency treated the event seriously.
The FDA classified this as a Class I recall. Class I is the most serious category the agency uses. It signals a reasonable probability of serious harm or death. However, a classification describes risk, not confirmed outcomes. It reflects how dangerous a defect could be if a consumer is exposed.
The agency record does not state whether any injuries were reported. As a result, this guide makes no claim either way. We will not say people were hurt. We will also not say no one was hurt. Typically, the safest step is to treat a Class I recall with real caution regardless.
Below is a quick reference table drawn from the verified agency data. It summarizes the core facts of the haleon us recall in one place. Use it to confirm the recall number and severity.
| Detail | Value |
|---|---|
| Recall number | D-0595-2026 |
| Issuing agency | U.S. Food and Drug Administration |
| Recall date | June 17, 2026 |
| Company | Haleon US Holdings LLC |
| Units affected | 35,883 |
| Severity classification | Class I |
What To Do If You Own This Product
First, stop using the product if it matches the haleon us recall. Do not take any more softgels from an affected package. This is the simplest way to reduce your risk. For example, set the box aside where no one will grab it by mistake. Safety comes before convenience here.
Next, confirm the match carefully. Look at the product name, the 125 mg simethicone strength, and the softgel form. Then check the UPC against 3 00674 35041 9 or 3 00439 00572 1. In most cases, the UPC and recall number together give a clear answer. Keep the packaging until you have finished this check.
The agency record for this recall contained remedy text that did not match the product. As a result, that remedy language has been withheld here. This guide will not state what the remedy is. Instead, follow the instructions in the official notice linked on this page. The official notice is the authoritative source for next steps.
For contact and instructions, use the FDA notice for this recall. You can review the enforcement listing at the FDA recall database for the current record. Typically, the notice will explain how to handle affected units. Keep any receipts or photos in case they are requested. When in doubt, ask your pharmacist.
Does a Haleon Us Recall Mean You Can Sue?
A recall is a safety action. It is not a lawsuit. The haleon us recall is a step by a company and a regulator to address a defect. It does not, by itself, create a legal claim for any consumer. This is an important distinction to keep in mind. Many people confuse the two.
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A lawsuit usually requires more than a recall notice. In general, a person must show a real injury. They must also show that the recalled product caused that injury. This link is called causation. Without injury and causation, a recall alone is not a claim. For example, owning a recalled box is not the same as being harmed.
If you believe a recalled product hurt you, seek professional advice. A licensed attorney can review your facts and your state’s rules. You may be eligible to pursue a claim in some situations. However, no one can promise an outcome or compensation. Every case turns on its own evidence and law.
Be cautious with any source that guarantees money. No article, and no ad, can tell you that you are owed anything. Typically, an honest lawyer will explain both the risks and the limits. As a result, a free consultation is a reasonable first step. It costs nothing to ask questions.
How Recalls Connect to Mass Tort Cases
A recall can become evidence in later litigation. It often documents a defect, a date, and a company response. In some mass tort cases, plaintiffs point to recall records to show a known problem. However, a recall is only one piece of a much larger picture. Courts still require proof of harm and causation.
History offers well-known examples of recalls that preceded litigation. The Philips CPAP recall over foam breakdown led to extensive product liability claims. The Takata airbag recall, one of the largest ever, also produced sprawling litigation. In both examples, recalls raised questions that later cases explored in depth. Still, each claim depended on individual facts and expert evidence, not the recall alone.
Frequently Asked Questions
How do I know if my Gas-X is part of the haleon us recall?
Check the product against the recalled sizes. Look for Gas-X Extra Strength SoftGels at 125 mg simethicone. Then match the UPC to 3 00674 35041 9 or 3 00439 00572 1.
Were any injuries reported in this recall?
The FDA record does not state whether injuries were reported. As a result, we cannot say either way. Treat the Class I recall seriously and follow the official notice for guidance.
Can I join a lawsuit because of this recall?
A recall by itself is not a lawsuit. You generally need an injury and a causal link to the product. Speak with a licensed attorney to learn whether you may be eligible.
Were You Injured by a Recalled Product?
A recall by itself is a safety action, not a legal claim. However, if a recalled product caused a real injury, you may be eligible to pursue compensation. A licensed attorney can review your situation at no upfront cost — most work on contingency, meaning you pay nothing unless you recover.
Official Sources & Resources
Verify every recall against the issuing agency before acting:
- U.S. Food and Drug Administration: official recall database — the record of truth for this notice
- CPSC: cpsc.gov — household goods, toys, furniture, appliances
- FDA: fda.gov — food, drugs, and medical devices
- NHTSA: nhtsa.gov — vehicles, tires, and child car seats
- USDA FSIS: fsis.usda.gov — meat, poultry, and egg products
Content last reviewed July 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.
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Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. A product recall is a safety action by a manufacturer or regulator and does not by itself establish liability or create a legal claim. No attorney-client relationship is created by accessing or using this content. Every case is unique. If you believe you were harmed by a recalled product, consult a licensed attorney in your jurisdiction.