← FDA ENFORCEMENT
D-0697-2026Class 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
5,801 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

TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670. NDC 63347-600-01

Code / lot info

Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.

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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.