FDA · Drugs ·
TERPENICOL Antifungal Cream (Undecylenic Acid 13%) recall
Blaine Labs Inc recalled TERPENICOL Antifungal Cream (Undecylenic Acid 13%) on July 8, 2026 because of cGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry. It was sold nationwide.
Why it was recalled
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
What's recalled
TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01.
Quantity: 22,143 bottles
What to do
Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.
Read the official FDA noticeDetails
- Company
- Blaine Labs Inc, Santa Fe Springs, CA
- Date
- Severity
- Class II
the product could cause temporary or reversible health problems. - Where sold
- Nationwide
Nationwide in the USA - Status
- Ongoing
- Recall number
- D-0695-2026
- Source
- U.S. Food and Drug Administration
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