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Class II · ModerateActive recall

Terpenicol

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

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

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byBlaine Labs, Inc., 11037 Lockport Place, Santa Fe Springs, CA 90670
Brand nameTERPENICOL
Generic nameUNDECYLENIC ACID
Active ingredient(s)UNDECYLENIC ACID
Distributed by / forBlaine Labs Inc
NDC63347-600-01
Show the full FDA record
Full product labelTERPENICOL 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
Recalling firmBlaine Labs Inc
DistributionNationwide in the USA
Quantity5,801 bottles
Recall initiated2026-04-08
Report date2026-07-08
Recall completed—
Recall numberD-0697-2026
ClassificationClass II
FDA statusOngoing
Origin on fileSanta Fe Springs CA United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.