← FDA ENFORCEMENT
D-0692-2026Class I

Blaine Labs Inc

Recalling firm
Blaine Labs Inc
Product type
Drug
Status
Ongoing
Report date
2026-07-08
Distribution
Nationwide in the USA
Firm state
CA
Product quantity
1,171 - 1 oz bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp

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.

Code / lot info

Lot#: BL3608, Exp. 07/01/28.

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Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.