Blaine Labs, Inc Issues Voluntary Nationwide Recall of Wound Care Gel Products Due to Microbial Contamination
Blaine Labs, Inc. has initiated a voluntary nationwide recall of three lots of Wound Care Gel (0.1% Benzalkonium Chloride) in 1 oz. and 3 oz. sizes due to microbial contamination.
This recall affects Blaine Labs, Inc., distributors, healthcare providers, and consumers utilizing these specific lots of topical wound care products.
Microbial contamination in topical wound care products poses a significant safety risk, particularly to immunocompromised users or those with open wounds. This action suggests a potential breakdown in sterility assurance or environmental controls during the manufacturing process, necessitating a review of current Good Manufacturing Practices (cGMP) for aqueous-based topical formulations.
QA teams should verify if any affected lots (1 oz. and 3 oz. Wound Care Gel) are in inventory and implement immediate quarantine procedures. Regulatory and manufacturing teams should review environmental monitoring and microbial testing protocols for topical aqueous products to mitigate contamination risks.
Santa Fe Springs, California – April 07, 2026 – Blaine Labs, Inc. is voluntarily recalling three (3) lot numbers of Wound Care Gel products, 1 oz. & 3 oz. (0.1% Benzalkonium Chloride) to the consumer level due to microbial contamination.
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