Tridergel Benzalkonium Chloride Wound Care Gel Recalled
Blaine Labs Inc is recalling Tridergel wound care gel nationwide due to current good manufacturing practice (CGMP) deviations. The product was manufactured in a facility under the same conditions as contaminated product.
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. The source text states CGMP deviations and manufacturing conditions related to contaminated product, but does not report any actual contamination, illnesses, or injuries. The hazard is regulatory non-compliance and potential cross-contamination risk without confirmed harm.
Plain-English summary
Blaine Labs Inc is recalling TRIFLUENT PHARMA TRIDERGEL Wound Care Gel (Benzalkonium Chloride 0.1%), 1.0 fl oz (29.6 mL) bottles nationwide in the United States. The recall affects approximately 519 units from Lot #BL3435 with an expiration date of 11/06/26.
The U.S. Food and Drug Administration identified current good manufacturing practice (CGMP) deviations related to the product being manufactured in the same facility under the same conditions as product found to be contaminated.
Consumers who have purchased this product should stop use immediately. For questions or to report any adverse effects, consumers should contact their healthcare provider or report the incident to the FDA.
The recalled product
- Product
- TRIDERGEL (BENZALKONIUM CHLORIDE)
- Brand
- TRIDERGEL
- Manufacturer
- Blaine Labs Inc
- Category
- Drug — Topical Wound Care
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 (2)
- Lot #: BL3435
- Exp. 11/06/26
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 →Related recalls
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