Voluntary Spray Recall | Lotrimin® | Lotrimin US and Esp
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Bayer Issues Voluntary Recall of Specific Lotrimin® and Tinactin® Spray Products Due to the Presence of Low Levels of Benzene
 

What You Need to Know

To request a refund, consumers may fill out this form.

You may have noticed that certain aerosol Lotrimin® and Tinactin® Spray Products are not available where you shop in the United States. That’s because Bayer has made the decision to voluntarily recall all unexpired Lotrimin® AF and Tinactin® spray products with lot numbers beginning with TN or CV to the consumer level due to low levels of residual solvent benzene detected in some samples of the final product. While benzene is not an ingredient in any of Bayer Consumer Health products, testing of these spray products commissioned by our contract manufacturer identified the presence of low levels of benzene in some samples.

It is important to note that Bayer’s decision to voluntarily recall these products is a precautionary measure and that the levels detected are not expected to cause adverse health consequences in consumers.

The recall relates only to certain Lotrimin® AF and Tinactin® spray products. There are no issues of concern with Lotrimin®/Tinactin® creams, including Lotrimin® Ultra, or any other Bayer products.

Consumers should stop using the affected products, follow the instructions set forth below, and once these steps are completed, appropriately discard these products.

Which Products Were Voluntarily Recalled?

The antifungal aerosol spray products, sold individually or in combo packs, impacted are:

  • Lotrimin® Anti-Fungal (AF) Athlete's Foot Powder Spray
  • Lotrimin® Anti-Fungal Jock Itch (AFJI) Athlete's Foot Powder Spray
  • Lotrimin® Anti-Fungal (AF) Athlete’s Foot Deodorant Powder Spray
  • Lotrimin® AF Athlete's Foot Liquid Spray
  • Lotrimin® AF Athlete’s Foot Daily Prevention Deodorant Powder Spray
  • Tinactin® Jock Itch (JI) Powder Spray
  • Tinactin® Athlete’s Foot Deodorant Powder Spray
  • Tinactin® Athlete’s Foot Powder Spray
  • Tinactin® Athlete’s Foot Liquid Spray

Product images and information on which lot numbers fall under this recall are available here.

Benzene

Benzene is found in the environment from natural sources and human activity. Humans around the world are exposed to it from multiple sources and pathways, including inhalation, through the skin, and orally. It is, however, classified as a human carcinogen and could potentially cause cancer depending on the level and extent of exposure.

Based on exposure modeling and the Environmental Protection Agency’s (EPA) framework, daily exposure to benzene from these spray products at the levels detected in testing would not be expected to cause adverse health consequences.

Consumer Guidance

Consumers should stop using these specific aerosol products and may request a refund by visiting www.lotrimin.com or www.tinactin.com. A photo of the product is required in order to obtain a refund. Consumers may also contact Bayer with questions by calling 1-866-360-3266, Monday-Friday between the hours of 8 a.m. and 8 p.m. Eastern Time. Consumers should contact their physician or healthcare provider if they have any questions, concerns or have experienced any problems related to using these aerosol antifungal products. Please follow your local disposal procedure for aerosol products once you have taken a photo and completed the process for obtaining a refund if you are requesting one.

Adverse reactions or quality problems experienced with the use of this product may be reported to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program by:

This voluntary recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

You can read our press release here.

 

FAQ

  1. How are the aerosol products different from the cream versions? Should consumers be concerned the creams are contaminated?
    • There are no issues of concern regarding the cream versions of these products; only the aerosol spray versions are affected and are being recalled. Cream and spray versions of these products contain the same active ingredients to fight athlete’s foot and jock itch, but the spray versions contain an additional ingredient known as a propellant that pushes the product out of the can as an evenly distributed spray. The low levels of benzene found in some samples of affected final spray products were traced to the propellant which is why only aerosol spray versions of the products are affected and subject to this recall.
       
  2. How do we know these are the only affected products? Do you expect to make any additional recalls of these or similar products?
    • The company and/or its contractors have been testing other aerosol spray products and have not identified any other spray products that are affected. The focus has been on spray products as it was the propellant in Lotrimin and Tinactin aerosol spray cans that was found to contain low levels of benzene. Prior to these issues arising, we had already transitioned to a different contract manufacturer that is not impacted by this issue.
       
  3. How do I get a refund? Is there any proof of purchase required? Is there a date by which I need to request a refund?
    • To request a refund, consumers should visit www.lotrimin.com or www.tinactin.com and submit a web form and a refund will be sent to them.
    • A photo of the product will need to be submitted to receive a refund.
    • Alternatively, consumers can request a refund by contacting Bayer’s call center at 1-866-360-3266 Monday through Friday between the hours of 8 a.m. and 8 p.m. Eastern Time
    • No deadline for refund requests has been set at this time but we encourage consumers to submit their requests as soon as possible.
       
  4. What should consumers do if they have unused products? Should they destroy it or return it somewhere?
    • Consumers should stop using the affected products and appropriately dispose of them as they normally would any spray can products. Consumers are required to submit a photo of the product to obtain a refund so the refund process should be completed prior to disposing the product.