Class I U.S. Food and Drug Administration

Blaine Labs Inc Revitaderm Wound Care Gel, Benzalkonium Chloride 0.1% recall: Microbial contamination of Non-Sterile Product: samples identified

Recall published 4 months ago

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

The hazard: Microbial contamination

This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

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

Why it matters: The product was found, or is suspected, to carry a harmful micro-organism. The agency notice names the specific organism and that detail matters, because the illness it causes and the people most at risk differ from one to the next.

Symptoms and when to call a doctor

Most foodborne infections cause stomach cramps, diarrhoea, nausea and sometimes fever, starting anywhere from hours to weeks after exposure depending on the organism. See a doctor for a high fever, bloody diarrhoea, vomiting that stops you keeping liquids down, diarrhoea lasting more than three days, or signs of dehydration. Infants, pregnant people, adults over 65 and anyone immunocompromised should seek advice earlier.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0692-2026
Published
July 8, 2026
Risk level
Class I
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Blaine Labs Inc
Product type
Prescription & OTC drugs
Units affected
1,171 - 1 oz bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot#: BL3608, Exp. 07/01/28.

Products covered by this recall

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.

Check your product

The notice names 11 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • BL3608
  • Exp. 07
  • 01
  • 28. — 1

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 07
  • 01
  • 28. — 1

NDC number

On the carton and again on the bottle or blister label.

  • 63347-120-02

Package size

Match the net weight or the piece count on the front of the pack.

  • 1.0 FL OZ
  • 37 mL
  • 1 oz

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Contamination

Blaine Labs Inc — This recall is a contamination finding. The product may be perfectly normal to look at, because testing — not appearance — is what caught it.

  1. Stop eating it and keep it separate from other food.
  2. If anyone who ate it is unwell, mention the recall and the date by name when you call a clinician.
  3. Bag and bin it, or return it to the store for a refund.
  4. Clean and sanitise the fridge shelf, container or surface it was stored on.

Getting a refund without the pack

The commonest reason people skip the refund is that they have already thrown the item away. That rarely matters.

  • A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.
  • Store credit is often offered first. You can ask for the original payment method instead, and it is normally granted.
  • No photo either? Ask anyway. Grocery chains settle recall refunds at the service desk because disputing them costs more than paying them.
  • For a multi-pack or a case, ask for the full purchase price rather than a per-unit figure — the recall covers what you paid.

Company contact: Blaine Labs Inc — 11037 Lockport Pl, Santa Fe Springs, CA, 90670-4634

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Blaine Labs Inc prescription & otc drugs recalled?

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

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code BL3608, Exp. 07, 01; best-by date 07 or 01. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it and keep it separate from other food.

Can I get my money back?

A photo of the label and lot code is accepted by most grocers, and so is a card statement line showing the purchase.

Where was the recalled product sold?

It was distributed nationwide.

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