FDAFDA recall D-0695-2026 · Jul 8, 2026
Blaine Labs Inc: TERPENICOL Antifungal Cream (Undecylenic Acid 13%) recall
Recall found
Product
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.
Reason for recall
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
What to do
FDA enforcement reports don't include consumer instructions. Check the codes below against your packaging. If this is a medicine or device you use, talk to your pharmacist or doctor before you stop or change anything, and contact the company or FDA for what to do with the product.
Recall details
- FDA classification
- Class II: use of or exposure to the product may cause temporary or medically reversible health problems, or the chance of serious problems is remote.
- Status
- Ongoing
- Codes, lots and dates
- Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027.
- Quantity
- 22,143 bottles
- Distribution
- Nationwide in the USA
- Recalling firm
- Blaine Labs Inc, Santa Fe Springs, CA
- Voluntary or mandated
- Voluntary: Firm initiated
- Recall started
- 2026-04-08
Source: openFDA enforcement record D-0695-2026 · search recall number D-0695-2026 in FDA's Enforcement Report.
Copied from the agency record without changes. Data as of Oct 22, 2026, 4:56 AM EDT. The agency notice is the final word.