Revitaderm Wound Care Gel recall
FDA recall D-0692-2026 · initiated Apr 8, 2026
Blaine Labs Inc recalled Revitaderm Wound Care Gel in Apr 2026 — an FDA Class I recall (D-0692-2026) because Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp.
Most serious — a reasonable probability that use will cause serious harm or death.
Why it was recalled
Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 1,171 - 1 oz bottles
Details
- Product
- 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.
- Recalling company
- Blaine Labs Inc
- Classification
- Class I
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 8, 2026
- FDA report date
- Jul 8, 2026
Frequently asked
- Was Revitaderm Wound Care Gel recalled?
- Blaine Labs Inc recalled Revitaderm Wound Care Gel in Apr 2026 — an FDA Class I recall (D-0692-2026) because Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp. Most serious — a reasonable probability that use will cause serious harm or death.
- Why was Revitaderm Wound Care Gel recalled?
- Per the FDA enforcement record, the reason for recall D-0692-2026 was: Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp
- Is a recalled Revitaderm Wound Care Gel dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Most serious — a reasonable probability that use will cause serious harm or death. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Revitaderm Wound Care Gel are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot#: BL3608, Exp. 07/01/28.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0692-2026.