FDAFDA recall D-0692-2026 · Jul 8, 2026
Blaine Labs Inc: Revitaderm Wound Care Gel recall
Recall found
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.
Reason for recall
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class I: FDA's most serious class, where use of or exposure to the product may cause serious health problems or death.
- Status
- Ongoing
- Codes, lots and dates
- Lot#: BL3608, Exp. 07/01/28.
- Quantity
- 1,171 - 1 oz bottles
- Distribution
- Nationwide in the USA
- Recalling firm
- Blaine Labs Inc, Santa Fe Springs, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-04-08
Source: openFDA enforcement record D-0692-2026 · search recall number D-0692-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.