Recalled Philips Dreamstation CPAP Machines

Philips Recalls Dreamstation CPAP Devices Because of Cancer Risk

Koninklijke Philips NV (Philips) has issued a recall of specific CPAP (continuous positive airway pressure) devices, which are part of the company’s first generation of Dreamstation CPAP line of products.

Their research discovered that that using the machines which are used to treat sleep apnea contain a component that can cause lung cancer and other illnesses.

Philips CPAPs contain sound abatement foam to minimize the noise emitted from the machines.
The foam, we now know, is prone to degradation, which can result in a hazardous situation for people using the CPAP machines.

What is Dangerous About Recalled CPAP Devices?

Philips produces millions of devices intended to help users breathe. The Dreamscape CPAP is part of its collection of devices used by people with sleep apnea. The CPAP continuously forces moist air through a hose and mask which are attached to the CPAP machine. The forced air prevents breathing interruptions and helps avoid the short and long-term effects that come with having sleep apnea.

The Philips CPAP devices contain acoustic foam. Its purpose is to minimize the noise the CPAP makes. Unfortunately, the foam poses health risks that resulted in the CPAP recall.
Philips learned that the type of foam they use in the Dreamstation CPAP devices could degrade, disintegrate, or fall apart.

It is unclear exactly what can cause the degradation but time, cleaning methods, and humidity are possible culprits.

When the foam degrades, it reduces to tiny particles that can get into the air tubes of the CPAP machine. Those foam particles are then inhaled or ingested by the unsuspecting user and contribute to the development of several adverse health conditions, including lung cancer.

There is also some concern that users of the recalled CPAP devices might also be exposed to breathing dangerous chemicals emitted by the foam due to off-gassing.

Recalled CPAP Devices Can Cause Cancer and Other Ailments

When your body is exposed to degraded foam particles, various adverse health conditions can result. When you repeatedly breathe or ingest dangerous materials like those found in the recalled CPAP devices, you are at risk of developing severe illnesses. If you used the recalled CPAP machines, Philips put you in danger of having:

  • Throat irritation
  • Airway irritation
  • Severe headaches
  • Lung cancer
  • Other cancer
  • Inflammation of your airway and other parts of the body
  • Respiratory ailments like coughing and breathing trouble

Currently, Philips has not received any reports of death associated with the noise abatement foam in its recalled CPAP devices. It has, however, received notification that foam degradation in these machines has had a possible impact on users.

While there have been no reports that off-gassing from the recalled CPAP has caused injuries, it is important to be aware of the risks. Off-gassing can cause many of the same symptoms as breathing or ingesting tiny particles of toxic materials like foam. In addition to cancer, exposure to off-gassing can also result in hypersensitivity, nausea, and vomiting.

What Should You Do If You Use One of The Recalled CPAP Devices?

Philips told patients using the recalled Dreamstation CPAP machines to stop using them immediately and speak to their health care provider about alternative, safer sleep apnea devices that might be available. Not all CPAP machines contain the same noise-abatement foam, which suggests that the design of this recalled device might have posed an unnecessary risk to its users.

If You Developed Lung Cancer After Long-Term Use of a Philips CPAP, You Might Be Entitled to Compensation

If you used a CPAP made by Philips and were diagnosed with lung cancer, you might be able to file a lawsuit. Call our Philips CPAP cancer lawyers at Alonso Krangle, LLP, to find out if you can hold Philips accountable for your injuries and collect substantial compensation.

Call our CPAP recall lawyers today at 800-403-6191 for a free evaluation of your Philips CPAP lung cancer claim.

Phillips Recall of Bi-Level PAP Devices

Philips Recalls Dreamstation Bi-Level PAP Sleep Apnea Devices

Royal Philips (Philips) has issued a recall of some of its bi-level PAP devices which are used by individuals who suffer from sleep apnea. Philips Chief Executive Frans van Houten estimated that up to four million devices would be targeted in the recall.

Philips has determined that these devices contain materials that pose potentially life-threatening risks for users. The noise-reducing foam in these machines can degrade, and users can inhale or ingest particles that are dangerous. Most of the recalled bi-level PAP devices are from Philips’ first line of Dreamstation sleep apnea machines.

What Should You Do If You Use A Bi-Level PAP Machine That Was Recalled?

In its press release, Philips advises users of its recalled Bi-Level PAP to stop using the device and contact their doctor about safer alternatives.

Philips is preparing to replace the PE-PUR foam in the Bi-Level PAP devices with noise abatement materials that do not present the same dangers associated with degradation and the resulting risks of lung cancer and other harmful illnesses.

Bi-Level PAP Devices Contain Dangerous Foam That Might Cause Cancer

The Bi-Level PAP machines (and other CPAP products made by Philips) contain sound abatement foam referred to as PE-PUR. PE-PUR is short for polyester-based polyurethane, which is the basic component of the foam. The purpose of the PE-PUR foam is to reduce the noise the apnea machine emits when in use.

Philips recalled the Bi-Level PAP because,

“There are possible risks to users related to the PE-PUR sound
abatement foam component, including the possibility of the foam
degrading into particles that may enter the device’s air pathway and be ingested by the user.”

In its press release, Philips added that some external factors might contribute to or hasten the foam degradation, such as highly humid conditions or using certain cleaning methods on the device.

Philips warned that the PE-PUR foam might also produce chemicals through off-gassing. Inhaling or ingesting these chemicals can also contribute to various illnesses and injuries.

Lung cancer, in particular, often results from long-term exposure to dangerous particles and chemicals. There is an especially high risk of developing lung cancer when toxins enter your body, directly through your airway and respiratory system, as they can do in the case of the recalled Bi-Level PAP devices.

Recalled Bi-Level PAP Devices Can Cause Lung Cancer and Other Illnesses

When the acoustic foam degrades or falls apart, small particles of polyester-polyurethane can enter the airway system of the device. The users of the Philips Bi-Level PAP then breathe in the dangerous particles. When the toxic particles from the Bi-Level PAP PE-PUR foam enter the body, users are at risk of developing lung cancer and serious respiratory conditions.
Philips stated that in addition to lung cancer, the recalled Bi-Level PAP devices could cause inflammation, headaches and irritate your throat, airway, and bronchial tubes.

Philips claims to be monitoring the adverse effect reports associated with the recalled Bi-Level-PAP devices. It is aware of many reports of “possible patient impact” because of the noise-abatement foam in its Bi-Level PAP machines.

Philips claims to have received no reports of specific injuries related to the recalled PAP devices and “off-gassing” that can occur. Off-gassing can result in nausea, vomiting, and headaches, as well as increase your cancer risk. Again, at this time, the only adverse effect reports Philips is aware of are those related to the injuries caused by the Dreamstation Bi-Level PAP’s foam degradation.

If You Have Lung Cancer And Were A Long-Term User Of A Recalled Philips Bi-Level PAP Device, You Might Be Eligible For Compensation

Call our Philips Bi-Level PAP cancer lawyers at Alonso Krangle, LLP, to find out if you are able to seek damages for your injuries. If you used a recalled Philips Bi-Level PAP device and developed lung cancer or another serious illness, you might be able to hold Philips accountable and collect substantial compensation.

Call our Bi-Level PAP recall lawyers today at 800-403-6191 for a free evaluation of your Bi-Level PAP lung cancer claim.



Phillips Recall of Mechanical Ventilators

Philips Issues Urgent Medical Device Recall Of Mechanical Ventilators Because of Health Risks

Philips (also known as Philips Respironics and Royal Philips) has issued an urgent recall of several mechanical ventilators.

Philips reported to users that the recall was because of two issues related to the polyester-polyurethane (PE-PUR) foam used to lessen noise emitted by its continuous and non-continuous mechanical ventilators. The recall notice states that the foam presents danger because:

  1. “PE-PUR foam may degrade into particles which may enter the device’s air pathway and be ingested or inhaled by the user,” and
  2. “the PE-PUR foam may off-gas certain chemicals.” Philips acknowledged that these issues could result in life-threatening conditions for users of the recalled ventilators, including lung cancer.

What Ventilators Are Included in The Philips’ Recall?

According to Phillips, the recall applies to the following ventilators:

All devices (below) manufactured before 26 April 2021, All serial numbers

  • Continuous Ventilators- Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent
  • Continuous Ventilator, Minimum Ventilatory Support, Facility Use- A-Series BiPAP Hybrid A30, A-Series BiPAP V30 Auto, A-Series BiPAP A40
  • Continuous Ventilator, Non-life Supporting- A-Series BiPAP A40, A-Series BiPAP A30

What Should You Do If You Use A Recalled Ventilator?

Understanding that individuals who use mechanical ventilators might need them to sustain life, Philips recommends that users of the recalled ventilators do not stop or alter how they use the devices without consulting their doctors.

The patients should discuss alternative devices with their health care professionals and determine if they can switch to a ventilator that does not pose the same risks as those of the recalled ventilators. The benefits of continuing to use the recalled device may outweigh the risks of interrupting use. This is a decision that the patient and doctor must make.

If a determination is made that an individual must continue to use a recalled ventilator, Philips advises using an inline bacterial filter.

What Are The Health Risks Associated With Recalled Ventilators?

As stated earlier, the Philips mechanical ventilators have been recalled partly because of the serious dangers associated with the degradation of the PE-PUR foam. When the foam degrades into particles, the particles can enter the user’s airway.

Long-term exposure to toxic particles can cause lung cancer and other dangerous health conditions.

In its urgent medical device recall notice, Philips stated that it,

“has received several complaints regarding the presence of black debris/particles within the airpath circuit (extending from the device outlet, humidifier, tubing, and mask). Philips also has received reports of headache, upper airway irritation, cough, chest pressure and sinus infection. The potential risks of particulate exposure include: Irritation (skin, eye, and respiratory tract), inflammatory response, headache, asthma, adverse effects to other organs (e.g. kidneys and liver) and toxic carcinogenic affects.”

Regarding the issue of off-gassing, another reason for the recall, Phillips added,

“The potential risks of chemical exposure due to off-gassing include: headache/dizziness, irritation (eyes, nose, respiratory tract, skin), hypersensitivity, nausea/vomiting, toxic and carcinogenic effects. There have been no reports of death as a result of these issues.”

These injuries can be life-threatening and cause severe and permanent impairment to victims. It is critical that if you use one of the Philips ventilators, you speak to your doctor right away to determine if continued use of a recalled device is worth the risks

If You Have Lung Cancer And Use A Recalled Philips Mechanical Ventilator, You Might Be Eligible For Compensation

Call our recalled ventilator lawyers at Alonso Krangle, LLP, to find out if you qualify to file a lawsuit and seek damages for your injuries. When products like medical devices don’t work as they are supposed to or pose dangerous risks to users, the manufacturers might be legally responsible for the injuries they cause.

If you used a recalled Philips mechanical ventilator and were diagnosed with lung cancer or another serious health condition, you might be entitled to collect compensation.

Call our ventilator recall lawyers today at 800-403-6191 for a free evaluation of your dangerous medical device claim.


Penumbra JET 7 Catheter Recall and Injury Lawsuits

Serious Injuries Lead to Recall of Penumbra JET 7 Xtra Flex Catheters

At the end of 2020, Penumbra issued an “urgent voluntary medical device recall” of its JET 7 Xtra Flex Reperfusion Catheters because using them to remove blood clots in stroke patients presented an unexpected risk of death or serious injury to the patient.

Penumbra discovered that the distal tips of the JET 7 Xtra Flex catheters could become damaged, creating a dangerous situation for patients. After Penumbra recalled the catheters, the Food and Drug Administration (FDA) followed up by issuing an “urgent letter” to ensure important information about the recall reached all health care providers and facilities.

According to the FDA, the specific devices recalled by Penumbra are:

  • The JET 7 Xtra Flex catheter, originally cleared under K190010 on June 16, 2019.The JET 7MAX configuration, which includes the JET 7 Xtra Flex catheter and MAX Delivery Device, cleared under K191946 on February 27, 2020.
  • Penumbra’s Unique Device Identifiers (UDIs) are 00815948020962, 00815948021594, and 00815948020955.

Penumbra’s recall only applies to its Flex Tip catheters. It does not include its Jet 7 Reperfusion Catheters with Standard Tips

Why Do Doctors Use Penumbra JET 7 Xtra Flex Catheters?

Doctors use the JET 7 Xtra Flex catheter to remove blood clots in stroke victims. Removing the clots restores blood flow.

The Penumbra JET 7 Xtra Flex catheter works in conjunction with a Penumbra aspiration pump and related tubing. The devices are necessary to perform a mechanical thrombectomy – or removal of blood clots. The equipment is used together to locate and vacuum out the blood clot, restoring blood flow to the victim.

Doctors insert the catheter and guidewire through an artery in the groin. The wire and catheter continue to wind through the artery until the device reaches the clot. Doctors use continuous imaging resources to guide the catheter and locate the source of the blockage. Once they find it, they use their equipment to suck the blood clot through the catheter. Doctors then pull the catheter back out of the body through the groin.

Patients who undergo this procedure are typically individuals who do not respond or cannot take to clot-busting medication.

What are the Dangers of the Penumbra JET 7 Xtra Flex Catheters?

According to Penumbra, the distal tips of the Penumbra JET 7 Xtra Flex Catheters are prone to damage.

When they become damaged, they cannot withstand “pressurization or contrast injection,” both of which are necessary parts of the mechanical thrombectomy procedure. Penumbra’s own tests revealed that the Flex tip catheters could not withstand the same bursts of pressure as its Standard tip catheters used for the same purposes.

According to the FDA urgent letter to healthcare providers, medical device failure reports include “ballooning, expansion, rupture, breakage or complete separation, and exposure of internal support coils near the distal tip region of the JET 7 Xtra Flex catheter.”

These failures associated with the JET 7 Xtra Flex catheters contributed to “deaths, injuries, and serious malfunctions.” Specific injures reported include bleeding, vessel damage, stroke, and related damage to the brain.

Penumbra’s recall advised healthcare providers to stop using the JET 7 Xtra Flex catheters immediately, remove them from their inventory and return the devices to Penumbra.

Alonso Krangle, LLP, is Reviewing JET 7 Recalled Catheter Cases

Did you or someone you love suffer a stroke and have a procedure with the Penumbra JET 7 Xtra Flex Catheter? Were there additional injuries after having a blood clot removed with one of the recalled devices?

If you think a Penumbra catheter injured you or a family member, call our lawyers at Alonso Krangle, LLP to determine if you are entitled to file a lawsuit against Penumbra.

If you or a family member suffered injuries because of a recalled medical device, you might be entitled to substantial compensation. Call our Jet 7 recall lawyers today at 800-403-6191 for a free evaluation of your claim.


Philips CPAP Recall and Injury Lawsuits

Our Lawyers are Evaluating Philips CPAP and Ventilator Claims

Our experienced lawyers at Alonso Krangle, LLP want to ask you a few questions:
Have you been diagnosed with lung cancer? Have you been using a Philips CPAP machine for sleep apnea? Have you been using a Philips ventilator?

If so, you might be entitled to file a Philips CPAP lawsuit and collect substantial compensation. Philips has recalled many of its devices because they have a defect that can increase the risk of developing cancer and other dangerous side effects.

How do you know if you might qualify to file a Philips CPAP cancer lawsuit? At the very least, you must:

Have received a diagnosis of lung cancer and

  • Used a Philips CPAP machine (continuous positive airway pressure device) or
  • Used a Philips Bi-level PAP machine (positive airway pressure device) or
  • Used a Philips mechanical ventilator

If you developed lung cancer while using one of these dangerous devices, Philips might owe you compensation for your injuries. Our lawyers at Alonso Krangle, LLP, are providing free evaluations of CPAP claims to determine who is eligible to file a lawsuit. Call us today at 800-403-6191.

Philips Recalled CPAP Devices Because of Cancer Risk

Millions of people use machines to help them battle the effects of sleep apnea. Apnea is a condition characterized by disruptions in breathing that adversely affects the sleep cycle. Apnea is known to cause various health problems when it is not treated. Philips is one of the many companies that manufacture sleep apnea and ventilator devices.

In June 2021, Philips issued a voluntary recall of certain CPAP and ventilator models because using them can increase your risk of developing lung cancer. The recall primarily affects the Philips CPAP machines from the first generation of its Dreamstation line. It also affects some of its Bi-level PAP machines and mechanical ventilators.

The company was alerted in April 2021 that the noise-abatement foam in these devices can degrade into particles. The particles then can make their way into the airway portion of the devices. Inhaling, ingesting, or absorbing these particles can increase your risk of lung cancer and other injuries.

Philips claims to be taking steps to remedy the dangers associated with its CPAP devices. But, it might be too late for many users of these defective CPAP and Bi-level PAP machines. If you got a lung cancer diagnosis after using a CPAP machine, filing a lawsuit might be your chance to hold Philips accountable for exposing you to unnecessary risks and causing your injuries.

What Should You If You Use a Recalled CPAP Machine?

Philips has advised that if you use the recalled CPAP and Bi-level PAP machines, stop immediately and speak to your doctor about alternatives devices to address your sleep apnea. If you use one of the recalled ventilators, do not do anything without consulting your physician.

Foam In Recalled CPAP Machines Can Degrade and Cause Illnesses

The purpose of the foam in sleep apnea devices and ventilators is to reduce noise. Unfortunately, the foam might degrade because of time or other factors like humidity. When it degrades, particles can be ingested, absorbed, or inhaled by the users and contribute to illnesses including lung cancer.

  • Exposure to degraded foam might also lead to:
  • Asthma
  • Headaches
  • Nausea
  • Dizziness
  • Irritation to the eyes, throat, respiratory tract
  • Respiratory problems
  • Coughing
  • Inflammation
  • Vomiting
  • Skin irritation
  • Liver damage
  • Kidney damage
  • Toxic/Carcinogenic effects including lung and other cancer

What Compensation Can You Collect in a Successful CPAP Lawsuit?

If you have developed lung cancer or experienced some of the other ailments associated with foam degradation in CPAP machines, you might be entitled to file a lawsuit and collect substantial compensation. Damages in a successful CPAP lawsuit might include:

  • Medical costs like visits to the doctor, medications, assistive devices, nursing care, co-pays, and more
  • Lost wages for work you miss because of your illness (treatment days, doctor’s appointments, sick days)
  • Lost future income should you be unable to return to work because of your illness
  • Pain and suffering
  • Punitive damages if the court or jury determines that Philips was grossly negligent or acted intentionally to cause harm

If you get a cancer diagnosis after using a Philips CPAP, Philips Bi-level PAP, or a Philips mechanical ventilator, shouldn’t you receive compensation for your injuries? If Philips knew the devices were dangerous, should have provided warnings about the possible risks of using its machines, or could have made them safer, the company might have the legal responsibility to compensate injured victims.

Call Alonso Krangle, LLP, To Find Out if You Qualify to File a Philips CPAP Lawsuit

Call our experienced lawyers today at 800-403-6191 to find out if you are eligible to file a Philips CPAP cancer lawsuit. Your case evaluation is free, confidential and at no risk to you.

We have the experience and determination to ensure that you and your family collect the maximum compensation allowed by law when you are injured by a dangerous or defective medical device like a Philips CPAP. Call our CPAP recall lawyers today at 800-403-6191 to protect your legal rights.

Cancer Caused by Benzene Poisoning and Exposure

Benzene: Substance in Sunscreen and Other Products Causes Cancer

Why are people suddenly talking about benzene? Because recently, the independent research company Valisure found this cancer-causing solvent in many sunscreens, the very products we slather all over bodies to prevent cancer. Valisure has asked the Food and Drug Administration (FDA) to recall the benzene-containing products for two reasons:

  1. Because some of the sunscreens it tested contain more than allowable levels of benzene, and
  2. Because benzene is not necessary to making effective sunscreen, it should not be in there at all.

Let’s take a closer look at benzene and why it is dangerous to humans.

What is Benzene?

Benzene is a chemical solvent. According to the American Cancer Society (ACC), it is a colorless, flammable liquid with a sweet smell and evaporates quickly when exposed to air. Benzene is found in nature, forming after volcanoes or forest fires. Most human exposure to benzene, however, comes from its industrial use.

Benzene is a commonly used solvent in the US that is usually used to make other chemicals and substances. It is widely used to make plastics, rubber, lubricants, dyes, drugs, detergents, and pesticides. Benzene is also a byproduct of cigarette smoke, as well as crude oil and gasoline.
Benzene is, therefore, also part of car emissions or exhaust.

Many organizations have established that benzene causes cancer in humans. The International Agency for Research on Cancer (IARC), part of the World Health Organization (WHO), the National Toxicology Program (NTP), and the Environmental Protection Agency (EPA) all classify benzene as “carcinogenic to humans,” known to be a human carcinogen, and a “known human carcinogen,” respectively.

The FDA regulates the use of benzene when it is an ingredient in food, drugs, and cosmetics.
In a nutshell, the FDA allows benzene in drugs and cosmetics when it is unavoidable. However, when using benzene is unavoidable, it must be limited to 2 parts per million (ppm).

What Types of Cancer Does Benzene Cause?

Studies involving humans and animals conclude that benzene can cause cancer. Most research on the connection between benzene and cancer has focused on blood cancers.

Evidence shows a link between benzene exposure and the following cancers:

  • Leukemia
  • AML – acute myeloid leukemia
  • Childhood leukemia, childhood AML
  • Acute lymphocytic leukemia (ALL)
  • Chronic lymphocytic leukemia (CLL)
  • Multiple myeloma
  • Non-Hodgkin lymphoma

Blood cancers caused by benzene can affect the lymphatic system, plasma system, and bone marrow. All blood cancers adversely affect your body’s ability to fight infections.

  • For people with leukemia, cancer in your bone marrow and blood causes a very fast increase in the production of abnormal white blood cells. This results in an inability to fight infection as well as an inability to produce platelets and red blood cells.
  • Lymphoma involves the growth of cancer cells in your lymphatic system. Abnormal white blood cells form, and healthy lymphocytes become lymphoma, pooling in your lymph nodes and other tissues.
  • Myeloma affects your white blood cells and prevents your body from producing needed antibodies.

According to the Leukemia & Lymphoma Society (LLS), approximately 1.2 million people living in the US are either in remission or living with blood cancer. Unfortunately, someone in the US dies from blood cancer about every 9 minutes. Many blood cancers are caused by smoking, radiation, and exposure to chemicals like benzene.

Does Benzene Cause Other Health Problems?

Benzene has short and long-term effects in addition to cancer.

In the short term, breathing in benzene can cause dizziness, headaches, confusion, unconsciousness, drowsiness, and tremors. Ingesting food or water containing benzene can cause vomiting, convulsions, a rapid heartbeat, and even death. Skin exposure to benzene can result in blisters and redness. The presence of benzene in the air can also irritate the eyes and throat.

Long-term benzene exposure can cause blood disorders that are not cancerous but dangerous nonetheless.

Anemia, low platelets, and low white cell counts can occur. These can severely decrease your body’s ability to fight off infections and can lead to death.

There is also some evidence, although it is not conclusive, that long-term exposure to benzene can affect the reproductive organs of women. Research found that women exposed to benzene had irregular menstrual cycles and shrunken ovaries. It is unknown whether benzene affects a fetus or male fertility.

Can You Avoid Benzene?

Benzene is found in the air and many products, and it might be impossible to eliminate it from your life. For example, you might have a job that exposes you to benzene.

But, there are steps you can take to try to limit your exposure to benzene. For example, don’t smoke and avoid second-hand smoke as much as possible.

Try to avoid being around idling cars.

Avoid exposure to products containing benzene as much as you can. Know what is in the products you are using on your skin.

Call Our Benzene Cancer Lawyers at Alonso Krangle, LLP, If You Think Benzene Exposure caused your Cancer

If you or someone you love was exposed to benzene and diagnosed with leukemia, lymphoma, or myeloma, call our lawyers at Alonso Krangle, LLP. You might have the legal right to collect compensation for your injuries.

Call us today at 800-403-6191 to schedule a free evaluation of your benzene cancer claim.

Will FDA Recall Contaminated Sunscreen?

Valisure Asks The FDA To Recall Sunscreen Due To The Presence of Carcinogen

After conducting tests, the independent research company Valisure, LLC determined that 78 sunscreens and aftercare products contain benzene, a dangerous carcinogen. The Food and Drug Administration (FDA) classifies sunscreen as a drug subject to their regulations. The FDA also regulates aftercare products such as lotions under the category of cosmetics.

Some of the products tested contained high levels of benzene, which is an industrial chemical known to cause cancer. Valisure has sent a citizen petition to the FDA, asking the agency to recall the contaminated batches of sunscreen. Valisure would also like the FDA to revisit its guidelines regarding benzene in cosmetics and drugs.

What is Benzene?

Benzene is an industrial chemical solvent widely used in the US. According to the CDC, it is one of the top 20 chemicals for production volume.

Benzene is often used to create other chemicals, which are then used to make resin, plastics, nylon, and synthetic fibers. Benzene can also be used to make pesticides, lubricants, detergents, dyes, rubber, and drugs.

The National Institute of Occupational Safety and Health identifies several types of exposure to benzene that can be harmful: inhalation, digestion, skin absorption, eye contact, and skin contact.

Exposure to benzene can cause cancer, Leukemia, in particular. The chemical damages the bone marrow and decreases your body’s ability to make red blood cells. Anemia, cancer, and infections can result. Studies have also shown that exposure to benzene can affect a woman’s menstrual cycle and ovaries. Studies of animals indicate that inhaling benzene while pregnant affected the growth and bone marrow of animal fetuses.

Why is Benzene in Sunscreen?

Valisure has asked the FDA this very question. The rules about benzene state that it is a:

“Class 1 solvent” that “should not be employed in the manufacture of drug substances, excipients, and drug products because of their unacceptable toxicity … However, if their use is unavoidable in order to produce a drug product with a significant therapeutic advance, then their levels should be restricted,” and benzene is restricted under such guidance to 2 parts per million (“ppm”).”

This means that the FDA allows benzene in sunscreen if using benzene is unavoidable to produce the product. If it is unavoidable, benzene must be limited to 2ppm.

According to Valisure:

  • many of the sunscreens it tested and aftercare sun products contained benzene levels significantly higher than 2ppm.
  • many of the sunscreens it tested contained NO benzene, which suggests benzene is NOT necessary to the production of sunscreen. Using benzene is avoidable.

Valisure Asks the FDA to Recall Dangerous Sunscreens

In its petition, Valisure has asked the FDA to recall the batches of sunscreen and after-sun products containing high levels of benzene, a known human carcinogen. Valisure claims these products are “misbranded” and “adulterated.”

Valisure also wants the FDA to:

  • Investigate the manufacturing and process and documentation regarding sunscreen and aftercare products and adjust their labels accordingly.
  • Share information with the public about sunscreens not adulterated with benzene and the importance of using safe sunscreen to prevent skin cancer.
  • Develop guidance to analyze the use of benzene in sunscreen and related products
  • Revisit and revise and clarify its guidance regarding the use of benzene in drugs and cosmetics, including sunscreen, that does not require benzene for manufacturing.
  • Work with the Environmental Protection Agency to develop an initiative to address benzene contamination.

Will the FDA Recall Contaminated Sunscreen?

Valisure presented its petition to the FDA on May 24, 2021, and set forth what seems to be a logical argument supporting its request for a recall.

The FDA recommends the daily application of sunscreen to protect people from harmful UV rays. The FDA also prohibits the use of benzene in drugs unless it is unavoidable. If unavoidable, benzene must not exceed 2ppm. There is no controversy regarding the danger of benzene, and according to Valisure, it is unnecessary to use benzene in sunscreen products.

The frequency of sunscreen application and its absorption into the skin makes the presence of benzene in any amount particularly worrisome. Valisure has requested the FDA act promptly “given the high potential risk to public safety.”


Our Lawyers at Alonso Krangle, LLP represent victims injured by dangerous drugs and consumer products. If you or a loved one was diagnosed with cancer after possible exposure to benzene, call our office to schedule a free case evaluation and learn about your legal rights.
You might be entitled to collect compensation. Call Alonso Krangle, LLP today at 800-403-6191.