Blaine Labs recalls
FDA enforcement reports naming Blaine Labs Inc as the recalling firm.
- Recall reports
- 9
- Class I (serious)
- 2
- Most recent report
- Jul 8, 2026
- Jul 8, 2026TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1Drug · Blaine Labs IncCGMP Deviations; the firm discontinued required stability testing for products on the market still within expiryClass II
- Jul 8, 2026Revitaderm Wound Care Gel, Benzalkonium Chloride 0Drug · Blaine Labs IncMicrobial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus sppClass I
- Jul 8, 2026TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0Drug · Blaine Labs IncCGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminatedClass II
- Jul 8, 2026TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1Drug · Blaine Labs IncCGMP Deviations; the firm discontinued required stability testing for products on the market still within expiryClass II
- Jul 8, 2026vite20 Antifungal Cream, (10% Undecylenic Acid), 0Drug · Blaine Labs IncCGMP Deviations; the firm discontinued required stability testing for products on the market still within expiryClass II
- Jul 8, 2026TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1Drug · Blaine Labs IncCGMP Deviations; the firm discontinued required stability testing for products on the market still within expiryClass II
- Jul 8, 2026Fungal Fusion ERADICATION Solution, Antifungal & Antimicrobial KitDrug · Blaine Labs IncCGMP Deviations; the firm discontinued required stability testing for products on the market still within expiryClass II
- Jul 8, 2026Revitaderm Wound Care, First Aid Antiseptic Gel, Benzalkonium Chloride 0Drug · Blaine Labs IncCGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminatedClass II
- Mar 30, 2022REVITADERM WOUND CARE GEL, (Benzalkonium Chloride in a gel containing transforming grow…Drug · Blaine Labs IncMicrobial Contamination of Non-sterile Product; FDA analysis found the product to be contaminated with Bacillus cereus.Class I