← FDA ENFORCEMENT
D-0696-2026Class 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
26,475 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

vite20 Antifungal Cream, (10% Undecylenic Acid), 0.54 OZ (15 g) bottle, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, UPC 6 16728 00039 2.

Code / lot info

Lot BL3462, Exp. 2/7/2027

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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.