Critical Alert
Blaine Labs Inc Recalls Revitaderm Wound Care Gel
This is a Class I recall — the most serious type. There is a reasonable probability of serious health consequences or death.
Source: FDA
CriticalRecall #D-0692-2026Drug / Pharmaceutical
Blaine Labs Inc Recalls Revitaderm Wound Care Gel
Blaine Labs Inc · Class I — Most Serious
Product Description
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.
Reason for Recall
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
FDA Classification
Class I — Most Serious
A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Distribution
Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
Blaine Labs Inc is recalling a pharmaceutical product classified as Class I by the FDA — the highest risk level. The recall was initiated on April 8, 2026 affecting 1,171 - 1 oz bottles. Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp. It was distributed nationwide. Consumers and healthcare professionals should exercise caution and discontinue use of the recalled product. Contact the recalling firm directly for return or disposal instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.