FDA Drugs recall ·
Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%… recall
This is an FDA Class I recall — the most serious type.
- Recall number
- D-0692-2026
- Date
- (initiated April 8, 2026)
- Company / brand
- Blaine Labs Inc
11037 Lockport Pl, Santa Fe Springs, CA, United States - Category
- Drugs › Class I
- Classification
- Class I
- Status
- Ongoing
- Units affected
- 1,171 - 1 oz bottles
- Hazard tags
- Sterility Microbial contamination
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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 it recalled?
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot#: BL3608, Exp. 07/01/28.
Distribution
Nationwide in the USA
What does Class I mean?
Class I is the most serious FDA recall class: there is a reasonable probability that using or being exposed to the product will cause serious adverse health consequences or death.
Source: FDA (drugs), recall D-0692-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.