D-0692-2026 Class I Ongoing
FDA drug recall D-0692-2026 was initiated by Blaine Labs Inc on April 8, 2026 and is designated Class I. Reason for recall: Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp The recall status is ongoing. Affected quantity: 1,171 - 1 oz bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 8, 2026
- Initiation Date
- April 8, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 1,171 - 1 oz bottles
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
Distribution Pattern
Nationwide in the USA
Code Information
Lot#: BL3608, Exp. 07/01/28.