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

Revitaderm Wound Care, First Aid Antiseptic Gel recalled by Blaine Labs

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

Check your package

Lot, batch or date codesLots: (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

NDC63347-120

Quantity recalled5,555 bottles and tubes

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-0699-2026
FDA event ID: 98731
Recalling firm: Blaine Labs, Santa Fe Springs, CA
Brand: Revitaderm Wound Care
Manufacturer: Blaine Labs Inc.
Classification: Class II
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: Manufacturing (CGMP) Deviations
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

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

Product as listed by the FDA

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,

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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

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 II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

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 I	Revitaderm Wound Care Gel, Benzalkonium Chloride recalled by Blaine Labs	Blaine Labs	Sterility	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	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	Tripenicol S Antifungal Solution (Undecylenic Acid 25%) recalledTripenicol S	Blaine Labs	Potency & Assay	Nationwide
8 Jul 2026Drug	CLASS I	Revitaderm Wound Care Gel, Benzalkonium Chloride recalled by Blaine Labs	Blaine Labs	Sterility	Nationwide

Other Benzalkonium Chloride recalls

All 22

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Drug	CLASS II	Trifluent Pharma Tridergel Wound Care Gel recalled by Blaine LabsTridergel	Blaine Labs	Manufacturing (CGMP) Deviations	Nationwide
11 Mar 2026Drug	CLASS II	Cleansing Towelette (Benzalkonium Chloride 0.13%) recalledMed Nap Cleansing Towelette	Acme United	Manufacturing (CGMP) Deviations	Nationwide
11 Mar 2026Drug	CLASS II	Green Guard Antiseptic Wipes (Benzalkonium Chloride 0.13%) recalledGreen Guard Antiseptic Wipes	Acme United	Manufacturing (CGMP) Deviations	Nationwide
11 Mar 2026Drug	CLASS II	Dukal BZK Antiseptic Towelette (Benzalkonium Chloride 0.13%) recalledBzk Towelette	Acme United	Manufacturing (CGMP) Deviations	Nationwide
11 Mar 2026Drug	CLASS II	Medi-First Antiseptic Wipes recalled by Acme UnitedMedi-first Antiseptic Wipes	Acme United	Manufacturing (CGMP) Deviations	Nationwide