REVITADERM WOUND CARE
Recalling Firm / Manufacturer: Blaine Labs Inc
(Santa Fe Springs, CA, United States)
FDA Recall Number: D-0699-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
REVITADERM WOUND CARE
Generic Name
BENZALKONIUM CHLORIDE
Active Substance(s)
Benzalkonium Chloride
Administration Route
Topical
National Drug Code (NDC)
63347-120
Total Quantity Recalled
5,555 bottles and tubes
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Full Product Description
Packaging specifications and labeling details
Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0.1%) packaged as (a) 1.0 Fl OZ (16 mL) bottle, long pointy cap, NDC 63347-120-02; (b) 3.0 Fl OZ (85 g) tube, with short twist cap, NDC 63347-120-01; Manufactured By: Blaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670,
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
July 08, 2026
Firm Initiation Date
April 08, 2026
FDA Classification Date
Jul 16, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
Lots: (a) 1 oz - BL3435, Exp 11/06/26; BL3525, Exp 08/07/27. (b) 3 oz- Lots # BL3435, 11/06/26 & BL3525, 08/07/27
Distribution Information
Geographic scope of affected shipments
Nationwide in the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0699-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508601UTCC