Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 mL) bottle, shorter twist cap, Manufact
Summary
The FDA issued a Class I for Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, packaged in 1.0 FL OZ (37 by Blaine Labs Inc. Reason: Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp.
Details
Source
Drug Recall
External ID
D-0692-2026
Action Date
2026-07-08
Status
Ongoing
Category
drug
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.
Lot/Code Info: Lot#: BL3608, Exp. 07/01/28.
Quantity Affected: 1,171 - 1 oz bottles
Reason for Recall
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-08
Company
Santa Fe Springs, CA
Context & Analysis
This is a Class I recall. Class I recalls are the most serious — there is a reasonable probability that use of or exposure to the product will cause serious health consequences or death.
This was one of 48 drug recalls issued in the same week, part of 93 drug-related FDA actions this month.
Blaine Labs Inc has 9 FDA actions in our database, including 9 recalls.
Frequently Asked Questions
What is a Class I recall?
A Class I recall is the most serious type. The FDA has determined there is a reasonable probability that the product will cause serious adverse health consequences or death. Consumers should stop using the product immediately.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Blaine Labs Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Blaine Labs Inc have FDA actions?
Blaine Labs Inc has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0692-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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