TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz… was recalled on April 8, 2026 in cooperation with the U.S. Food and Drug Administration because CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry.
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.
Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027.
Units affected: 22,143 bottles
Where it was sold: Nationwide in the USA
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Class II means the product might cause a temporary or medically reversible health problem; the chance of serious harm is remote.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Blaine Labs Inc
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
Potential foreign object contamination: rubber pieces
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