CLASS I ONGOING Drug recall · Reported 8 Jul 2026 · FDA Enforcement Report

Revitaderm Wound Care Gel, Benzalkonium Chloride recalled by Blaine Labs

Blaine Labs is recalling Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1%, distributed nationwide in the US. The recall was initiated on 8 Apr 2026 and the FDA has classified it as Class I.

Check your package

Lot, batch or date codesLot#: BL3608, Exp. 07/01/28.

Quantity recalled1,171 - 1 oz bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0692-2026
FDA event ID: 98731
Recalling firm: Blaine Labs, Santa Fe Springs, CA
Classification: Class I
Status: Ongoing
Recall initiated: 8 Apr 2026
FDA classified: 16 Jul 2026
Reported: 8 Jul 2026
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Sterility
Drug class: Creams, Ointments & Gels

Timeline

8 Apr 2026	Recall initiated by company
8 Jul 2026	Published in enforcement report	+91 days
16 Jul 2026	Classified by FDA	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp

Which lots are affected?

Lot#: BL3608, Exp. 07/01/28.

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class I mean?

Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

7 other products · FDA event 98731

This product is part of a recall event; the main page for the event is Terpenicol Antifungal Solution, (Undecylenic recalled by Blaine Labs.

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026	CLASS II	Terpenicol Antifungal Solution, (Undecylenic recalled by Blaine LabsTerpenicol	Blaine Labs	Potency & Assay	Nationwide
8 Jul 2026	CLASS II	Fungal Fusion Eradication Solution, Antifungal & Antimicrobial Kit recalled	Blaine Labs	Potency & Assay	Nationwide
8 Jul 2026	CLASS II	Tripenicol S Antifungal Solution (Undecylenic Acid 25%) recalledTripenicol S	Blaine Labs	Potency & Assay	Nationwide
8 Jul 2026	CLASS II	Revitaderm Wound Care, First Aid Antiseptic Gel recalled by Blaine LabsRevitaderm Wound Care	Blaine Labs	Manufacturing (CGMP) Deviations	Nationwide
8 Jul 2026	CLASS II	vite20 Antifungal Cream, (10% Undecylenic Acid) recalled by Blaine Labs	Blaine Labs	Potency & Assay	Nationwide
8 Jul 2026	CLASS II	Trifluent Pharma Tridergel Wound Care Gel recalled by Blaine LabsTridergel	Blaine Labs	Manufacturing (CGMP) Deviations	Nationwide
8 Jul 2026	CLASS II	Terpenicol Antifungal Cream (Undecylenic Acid 13%) recalledTerpenicol	Blaine Labs	Potency & Assay	Nationwide

More recalls from Blaine Labs

All 9

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Drug	CLASS II	Terpenicol Antifungal Cream (Undecylenic Acid 13%) recalledTerpenicol	Blaine Labs	Potency & Assay	Nationwide
8 Jul 2026Drug	CLASS II	Trifluent Pharma Tridergel Wound Care Gel recalled by Blaine LabsTridergel	Blaine Labs	Manufacturing (CGMP) Deviations	Nationwide
8 Jul 2026Drug	CLASS II	vite20 Antifungal Cream, (10% Undecylenic Acid) recalled by Blaine Labs	Blaine Labs	Potency & Assay	Nationwide
8 Jul 2026Drug	CLASS II	Revitaderm Wound Care, First Aid Antiseptic Gel recalled by Blaine LabsRevitaderm Wound Care	Blaine Labs	Manufacturing (CGMP) Deviations	Nationwide
8 Jul 2026Drug	CLASS II	Tripenicol S Antifungal Solution (Undecylenic Acid 25%) recalledTripenicol S	Blaine Labs	Potency & Assay	Nationwide