Revitaderm Wound Care Gel Recall: What To Do

The blaine labs recall is a Class I safety action from the U.S. Food and Drug Administration. It involves Revitaderm Wound Care Gel made by Blaine Labs Inc. The FDA identified microbial contamination in this non-sterile product. As a result, 1,171 units were pulled from distribution. This guide explains what the recall covers and why it matters to you. If you keep this gel in your medicine cabinet, please read carefully.

What the Blaine Labs Recall Covers

The recalled product is Revitaderm Wound Care Gel. Its active ingredient is Benzalkonium Chloride 0.1%. The FDA recall number is D-0692-2026. The agency posted the action on July 8, 2026. This blaine labs recall applies to a specific bottle and cap design.

The affected product comes in a 1.0 FL OZ bottle. That equals about 37 mL. The FDA record notes a “shorter twist cap” on these units. The National Drug Code is NDC 63347-120-02. You can check this code on the label. For example, the numbers appear near the barcode on most drug packaging.

The manufacturer is Blaine Labs, Inc. The listed address is 11037 Lockport Place, Santa Fe Springs, CA 90670. In total, the blaine labs recall covers 1,171 units. That is a defined batch, not the entire product line. However, you should still verify your own bottle against the details above.

Typically, wound care gels like this are used at home. People apply them to minor cuts and skin irritation. As a result, contaminated product could reach open wounds. That is why the FDA treated this blaine labs recall seriously. The next section explains the specific hazard.

The Hazard and Reported Injuries

The hazard here is microbial contamination of a non-sterile product. FDA testing found bacteria in samples. Specifically, samples showed Lysinibacillus fusiformis and other Bacillus species. These are environmental bacteria. In most cases, they live in soil and dust.

Contamination matters most when a product touches broken skin. A wound care gel is applied directly to injured tissue. However, the FDA record does not state whether any injuries occurred. This guide will not claim that harm happened. It also will not claim that no harm happened. The agency record simply does not say.

The FDA assigned this action a Class I classification. Class I is the most serious recall category. It signals a reasonable probability of serious harm or death. That severity is why the blaine labs recall deserves prompt attention. Still, classification reflects potential risk, not a confirmed outcome.

The table below summarizes the verified agency data. Please use it to confirm your product details. For example, match the recall number and NDC to your bottle.

What To Do If You Own This Product

First, stop using the product right away. Do not apply it to any wound or skin. Set the bottle aside where children and pets cannot reach it. This is the safest first step for any Class I action.

Next, confirm that your bottle matches the recall. Check the product name, Revitaderm Wound Care Gel. Look for Benzalkonium Chloride 0.1% on the label. Verify the NDC 63347-120-02. Also note the 1.0 FL OZ size and the shorter twist cap. If these match, your bottle is part of the blaine labs recall.

The FDA record for this recall contains remedy text that does not match the product. For that reason, the specific remedy has been withheld here. Do not guess at the correct steps. Instead, follow the instructions in the official notice linked on this page. The official notice is the authoritative source for what to do next.

If you have health concerns, contact a licensed medical provider. For example, call your doctor if you used the gel on an open wound. You may also report problems to the FDA MedWatch program. Keep your bottle and receipt if possible. These records can help document your situation.

Does a Blaine Labs Recall Mean You Can Sue?

A recall is a safety action. It is not a lawsuit. These two things are very different. A company or agency issues a recall to remove a risky product. That step alone does not create a legal claim for you.

In most cases, a valid injury claim needs more than a recall. It generally requires an actual injury. It also requires causation. That means the product must have caused real harm. A blaine labs recall by itself does not prove either point. However, it may become useful background if harm did occur.

If you were hurt, speak with a licensed attorney. A lawyer can review your facts and records. They can tell you whether you may be eligible to pursue a claim. This guide makes no promises about compensation. No one can guarantee an outcome from a recall alone.

Be cautious with any source that promises money. You are not automatically owed anything because of a recall. As a result, treat bold guarantees with skepticism. A qualified attorney gives grounded, case-specific advice. That is the responsible path if you believe you were injured.

How Recalls Connect to Mass Tort Cases

Recalls sometimes become evidence in later litigation. A recall notice can document a known hazard. For example, plaintiffs may point to timing and testing details. However, a recall is only one piece of a much larger picture. Lawyers still must prove injury and causation in court.

History shows how this can unfold. The Philips CPAP recall led to broad mass tort litigation over foam breakdown. The Takata airbag recall drove years of claims over rupturing inflators. In both cases, the recall itself did not decide anything. Instead, it became one data point among many. The blaine labs recall may or may not ever follow that path, and this guide does not predict it will.

Frequently Asked Questions

What product is affected by the blaine labs recall?

The recall covers Revitaderm Wound Care Gel with Benzalkonium Chloride 0.1%. It comes in a 1.0 FL OZ bottle with a shorter twist cap. The NDC is 63347-120-02.

Why was the product recalled?

The FDA found microbial contamination in this non-sterile product. Samples showed Lysinibacillus fusiformis and other Bacillus species. The action was classified Class I, the most serious category.

How do I get the remedy for this recall?

The agency remedy text did not match the product, so it was withheld here. Please follow the instructions in the official notice linked on this page. That notice is the authoritative source for next steps.

Were You Injured by a Recalled Product?

A recall by itself is a safety action, not a legal claim. However, if a recalled product caused a real injury, you may be eligible to pursue compensation. A licensed attorney can review your situation at no upfront cost — most work on contingency, meaning you pay nothing unless you recover.

Official Sources & Resources

Verify every recall against the issuing agency before acting:

• U.S. Food and Drug Administration: official recall database — the record of truth for this notice
• CPSC: cpsc.gov — household goods, toys, furniture, appliances
• FDA: fda.gov — food, drugs, and medical devices
• NHTSA: nhtsa.gov — vehicles, tires, and child car seats
• USDA FSIS: fsis.usda.gov — meat, poultry, and egg products

Content last reviewed July 2026. This is general educational information, not legal advice. If you notice outdated information, please contact us.

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Attorney Advertising. The information on this page is provided for general informational purposes only and does not constitute legal advice. A product recall is a safety action by a manufacturer or regulator and does not by itself establish liability or create a legal claim. No attorney-client relationship is created by accessing or using this content. Every case is unique. If you believe you were harmed by a recalled product, consult a licensed attorney in your jurisdiction.