Tripenicol S Antifungal Solution 25% Recall: CGMP Deviations
TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213…
What is the FDA recall status?
The FDA record lists this recall as ongoing. FDA enforcement data is not a live recall-lifecycle tracker. Follow the official instructions and check the agency notice or firm for current guidance.
Why was Tripenicol S Antifungal Solution 25% recalled?
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
What should I do if I have this product?
Follow the firm and FDA instructions for the affected product. Contact the recalling firm for current guidance.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare your product with the product description and available lot, UPC or model codes below from the official FDA record to check whether it is covered by this recall. If an identifier is missing or unclear, check the complete official notice or contact the firm; an incomplete match here does not establish that your product is unaffected.
Full product description
TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01.
Which lot codes, UPCs or models are affected?
Lot #BL3411R, Exp 6/8/2027
- Agency record number
- D-0694-2026
- Product
- TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213…
- Recalling firm
- Blaine Labs Inc
- Quantity
- 144 bottles
- Distribution
- Nationwide in the USA
- Recall started
- April 8, 2026
- Report date
- July 8, 2026
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)