Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%

Blaine Labs Inc has recalled Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on July 8, 2026 and was initiated on April 8, 2026. It is classified as a Class I recall, which means there is a reasonable chance that using this product could cause serious health problems or death.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, with approximately 1,171 - 1 oz bottles affected. The company behind the recall is Blaine Labs Inc, based in Santa Fe Springs, CA. The FDA describes the product as: “Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufactured By: Blaine Labs, Inc. 11037 Lockport Place Santa Fe Springs, CA 90670, NDC 63347-120-02.”

Why was Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1% recalled?

According to the FDA, the stated reason for the recall is: “Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp.” In plain terms, this recall relates to a sterility or contamination concern.

Sterile medicines, such as injectables and eye drops, must be completely free of microorganisms and stray particles. This recall means that sterility could not be assured or that contamination was found or suspected. Using a non-sterile product of this kind can cause infections, which is why these recalls are treated seriously.

What should you do?

If you think you may have bought Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, compare it against the product description and identifying codes (Lot#: BL3608, Exp. 07/01/28.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Blaine Labs Inc or your local health authority.

About this recall

This recall was distributed in CA. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.