Manufacturer to Remove Benzene-Linked Chemical from Generic Mucinex Due to Cancer Concerns

The manufacturer of store brand versions of generic Mucinex that are sold by major retailers, including CVS and Walmart, has agreed to reformulate its version of the popular cold medication to eliminate an ingredient that can release benzene, which is a known cancer-causing chemical.

Brand-name Mucinex (guaifenesin), made by Reckitt Benckiser, uses carbomers to provide extended mucus relief for 12 hours. However, an investigation by Bloomberg News earlier this month revealed that the manufacturer of generic versions of the drug, Amneal Pharmaceuticals, uses a cheaper carbomer in its store-brand versions, which may turn into cancer-causing benzene when consumed.

Even though generic versions are supposed to be functionally equivalent to their brand name versions, the difference in carbomers is not mentioned on the label.

On August 13, Bloomberg issued a new report, indicating that Amneal Pharmaceuticals Inc. is planning to submit testing data to the U.S Food and Drug Administration (FDA) on a new formulation for generic Mucinex by the end of this year.

The drug maker has agreements with CVS Health, Walmart, Target and Rite Aid to produce their store-brand versions of extended-release Mucinex. The new product is expected to be on pharmacy shelves by August 2025.

The report also mentioned that similar carbomers have been used in other products, like Walgreens’ generic Anbesol, Walmart’s Equate face moisturizer with sunscreen and Rite Aid’s generic Bengay. CVS Health has announced that it is working with suppliers to change the carbomers used in its products to reduce the risk of benzene exposure.

The FDA had originally planned to ban all benzene in U.S. drugs by 2025, but the deadline was extended to 2026 after complaints from the pharmaceutical industry.

Benzene Exposure Risks

Benzene is a colorless chemical with a slightly sweet odor. It is highly flammable and often part of the chemical makeup of residential natural gas. If a natural gas leak occurs, the benzene can light on fire and lead to an explosion.

However, benzene is also known to be toxic. It has been linked to the formation of carbon monoxide, formaldehyde, and nitrogen dioxide–chemicals that are all toxic to human health.

Exposure to benzene emissions themselves can damage the immune system and has been linked to an increased risk of several fatal forms of cancer and life-threatening health conditions, such as acute myeloid leukemia (AML), Chronic Myelogenous Leukemia (CML), Acute Lymphocytic Leukemia (ALL), Chronic Lymphocytic Leukemia (CLL), Hairy Cell Leukemia (HCL), Non-Hodgkin’s Lymphoma, Multiple Myeloma, Myelodysplastic Syndrome (MDL), Myelofibrosis, Myeloid Metaplasia, Aplastic Anemia and Thrombocytopenic Purpura.

Long-term side effects of benzene exposure have been proven to cause anemia, which is a condition that develops when your blood lacks enough healthy red blood cells or hemoglobin.

Benzene Contamination Lawsuits

In addition to cold medications and other store-brand medications, high benzene levels have also been found in many aerosol spray products sold in recent years, leading to a number of sunscreen, deodorant and antiperspirant recalls.

A massive sunscreen recall was issued in 2021 over benzene contamination, after testing revealed dangerous benzene levels in 78 sunscreen and after-sun care products, with more than a quarter of products exceeding 2 parts per million (ppm).

Following the discovery, a number of similar recalls were issued over the next several years for sunscreen spray and mist products, including Neutrogena, Aveeno, and Banana Boat, as well as for deodorants such as products like Dove, Suave and Nexus, in addition to Old Spice and Secret.

In October 2023, a federal judge granted approval to a $3.1 million Batiste dry shampoo settlement agreement, which included a $2.5 million cash fund and $600,000 in vouchers for consumers who purchased the benzene-contaminated shampoo products. The settlement resolved a class action lawsuit filed against the manufacturer, Church & Dwight, Co., over benzene contamination in its dry shampoo spray products. The lawsuit stemmed from a Unilever dry shampoo recall issued in October 2022, after elevated benzene levels were detected from the spray can propellant used by the manufacturer.

Johnson & Johnson also faced a number of class action lawsuits over benzene contamination in its spray sunscreens. The court issued final approval for a Neutrogena and Aveeno spray sunscreen class action settlement in February 2023, in which Johnson & Johnson agreed to pay $1.75 million in vouchers to consumers who purchased benzene-tainted products following a 2021 recall.

However, an appeals court overturned the Neutrogena and Aveeno sunscreen settlement in June 2024, ordering a lower court to recalculate the voucher amounts and attorneys fees.

In addition to the class action claims seeking refunds, Johnson & Johnson still faces potential sunscreen cancer lawsuits brought on behalf of consumers who developed various forms of blood cancers following regular use of recalled Neutrogena or Aveeno products.