Undecylenic acid Recall: Blaine Labs Terpenicol Antifungal Cream
Announced 2026-07-08 · FDA
FDA recall of Blaine Labs Terpenicol Antifungal Cream (Undecylenic acid 13%), 1.0 oz bottles distributed nationwide. The recall cites CGMP deviations and that the firm discontinued required stability testing for products on the market still within expiry. Recalled lots BL3431R (Exp 10/13/26) and BL3528 (Exp 08/30/2027) total 22,143 bottles; no corrective action is listed.
| Brand | Blaine Labs Inc |
|---|---|
| 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 | CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry |
| Severity | moderate |
| Units affected | 5801 |
| Distribution | Nationwide in the USA |
| Agency | FDA |
| Recall / campaign no. | Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027. |
WHAT YOU SHOULD DO
- If you have recalled lots BL3431R or BL3528, stop using the product immediately.
- Keep the product in its original packaging and contact Blaine Labs for disposal, replacement, or refund instructions.
- Check the FDA recall page for updates and further guidance.
This is an automatically maintained record of an official recall notice. Details can change; always follow the official notice linked above. See all records in the Recall Database.