Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
REVITADERM WOUND CARE GEL Recalled by Blaine Labs Inc Due to Microbial Contamination of Non-sterile Product; FDA analysis found...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Blaine Labs Inc directly.
Affected Products
REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming growth factor-b), 0.1%, packaged in 29.6 mL (1.0 FL OZ) bottles (NDC 63347-120-02) and 88.7 mL (3.0 FL OZ) tubes (NDC 63347-120-01), Blaine Labs Inc., Santa Fe Springs, CA 90670
Quantity: 1119 (1 oz.) bottles/ 772 (3 oz.) tubes
Why Was This Recalled?
Microbial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Blaine Labs Inc
Blaine Labs Inc has 1 total recall tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report