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Class II · ModerateActive recall

Revitaderm Wound Care

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots: (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 it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byBlaine Labs, Inc. 11037 Lockport Place, Santa Fe Springs, CA 90670
Brand nameREVITADERM WOUND CARE
Generic nameBENZALKONIUM CHLORIDE
Active ingredient(s)BENZALKONIUM CHLORIDE
Distributed by / forBlaine Labs Inc
NDC63347-120-02
Show the full FDA record
Full product labelRevitaderm 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,
Recalling firmBlaine Labs Inc
DistributionNationwide in the USA
Quantity5,555 bottles and tubes
Recall initiated2026-04-08
Report date2026-07-08
Recall completed—
Recall numberD-0699-2026
ClassificationClass II
FDA statusOngoing
Origin on fileSanta Fe Springs CA United States

Related

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.