Blaine Labs recalls Revitaderm Wound Care gel due to contamination in the same facility as unsafe products. Affected lots include 1 oz and 3 oz sizes with specific expiration dates. Consumers should check their product details and contact Blaine Labs for guidance.
CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated
Blaine Labs is recalling Revitaderm Wound Care antiseptic gel because it was manufactured in the same facility as contaminated products. This poses a risk of infection or other health issues if used improperly.
The gel was produced in the same facility as products found to be contaminated, which could lead to harmful bacteria entering the wound. This increases the risk of infection or irritation, especially for individuals with open wounds or sensitive skin.
People who own or use Revitaderm Wound Care gel with the specific lot numbers and sizes listed in the recall notice are affected. Those with open wounds or sensitive skin may be at higher risk.
Check for the 1.0 fl oz (16 mL) bottle with a long pointy cap or the 3.0 fl oz (85 g) tube with a short twist cap. The product has specific lot numbers: BL3435 (expiring 11/06/26) or BL3525 (expiring 08/07/27).
Identify your gel by checking the cap type and size (1 oz bottle or 3 oz tube) and the lot numbers listed in the recall notice.
The recall states the product was manufactured in the same facility as contaminated products, so it may pose a risk of infection. Do not use until you confirm it's not affected.
Check the product details against the recall notice. If it matches, contact Blaine Labs for further instructions.
Look for the specific lot numbers (BL3435 or BL3525) and sizes (1 oz bottle or 3 oz tube) listed in the recall notice.
We’ve drafted a message you can send Blaine Labs to request your refund or repair — edit it as you like.
Subject: Recall D-0699-2026 — Blaine Labs Blaine Labs Hello, I own a Blaine Labs that is covered by recall D-0699-2026 from Blaine Labs. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
