FreshRecalls

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FDAClass II · Drug · Recalled July 8, 2026

Revitaderm Wound Care recall — Blaine Labs Inc

Hazard: CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0699-2026
Brand
Blaine Labs
Classification
Class II
Units affected
5,555 bottles and tubes
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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,

Affected products

Companies & origin

Recalling firm location
Santa Fe Springs, CA, United States
Firm address
11037 Lockport Pl, N/A, 90670-4634

Identifying details (verbatim from the notice)

Product codes / lots
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
Nationwide in the USA
Firm notified the public via
Press Release
FDA event ID
98731
Recall initiated
April 8, 2026
FDA classified
July 16, 2026
FDA report date
July 8, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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