Tridergel
FDA Recall NDC 73352-520

FDA Enforcement Report: View Recall Date, Reasons, and Safety Status

Active & Historical Enforcement Reports

The FDA has identified 1 recorded enforcement report(s) associated with Tridergel (NDC 73352-520). A significant event, classified as Class II, was initiated on Apr 08, 2026 by Trifluent Pharma Llc. The reported reason for this action was: "CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated"

This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.

Reported Recall Events

April 2026 Class II Recall: CGMP Deviations

Recall Number
Class II Ongoing
Reason for Recall
CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated
Initiated
Apr 08, 2026
Reported
Jul 08, 2026
Quantity
519 - 1 oz bottles

Recall Profile & Regulatory Data

Event ID
98731
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Blaine Labs Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA
Product Description
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, (Benzalkonium Chloride 0.1%), 1.0 fl oz, (29.6 mL) bottle with long pointy cap, Manufactured for: Trifluent Pharma, LLC. San Antonio, TX 78213. NDC 73352-520-01.
Batch or Lot Expiration Information
Lot# : BL3435, Exp. 11/06/26
Affected Packages Involved in this Recall
73352-520-01Product

About FDA Recall Enforcement Reports

FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.

If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.