← FDA ENFORCEMENT
D-0694-2026Class II

Blaine Labs Inc

Recalling firm
Blaine Labs Inc
Product type
Drug
Status
Ongoing
Report date
2026-07-08
Distribution
Nationwide in the USA
Firm state
CA
Product quantity
144 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

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.

Code / lot info

Lot #BL3411R, Exp 6/8/2027

Other recalls SPEQ maps to Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc
See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.