The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-0699-2026·Announced 2026-07-08

Revitaderm Wound Care Benzalkonium Chloride OTC Drug Recall

Blaine Labs Inc is recalling Revitaderm Wound Care (Benzalkonium Chloride 0.1%) topical antiseptic gel due to current good manufacturing practice (CGMP) deviations. The product was manufactured in the same facility under the same conditions as a product found to be contaminated.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall involving CGMP deviations at the manufacturing facility where a contamination event occurred. No specific illnesses, injuries, or confirmed contamination of the recalled product itself are reported in the source text, making it a precautionary recall based on manufacturing conditions rather than confirmed product defect.

Plain-English summary

Blaine Labs Inc is recalling Revitaderm Wound Care, a first aid antiseptic gel containing benzalkonium chloride 0.1%, distributed nationwide in the United States. The recall affects approximately 5,555 bottles and tubes.

The recall was issued due to current good manufacturing practice (CGMP) deviations. Specifically, the recalled product was manufactured in the same facility under the same conditions as another product that was found to be contaminated.

The recalled product is available in two package sizes: 1.0 fluid ounce (16 mL) bottles with long pointy caps (NDC 63347-120-02) and 3.0 fluid ounce (85 g) tubes with short twist caps (NDC 63347-120-01). Affected lot numbers include BL3435 (expiration 11/06/26) and BL3525 (expiration 08/07/27) for both package sizes.

Consumers who have purchased this product should stop using it immediately and contact Blaine Labs Inc or their healthcare provider if they have any health concerns.

The recalled product

Product
REVITADERM WOUND CARE (BENZALKONIUM CHLORIDE)
Brand
REVITADERM WOUND CARE
Manufacturer
Blaine Labs Inc
Category
Drug — Topical Antiseptic / Over-the-Counter
Hazard
Affected units
5,555

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (6)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 8 recalled by Blaine Labs Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 8 products in this recall →

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