TERPENICOL Antifungal Solution recall (Blaine Labs Inc)
DrugClass IIOngoing
Summary: Blaine Labs Inc is recalling TERPENICOL 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. Reason: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry.
What is being recalled
TERPENICOL 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
Why
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
How serious is it
Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.
Where it was sold
Nationwide in the USA
How to tell if yours is affected
Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0697-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class II |
| Status | Ongoing |
| Recall started | April 8, 2026 |
| Reported | July 8, 2026 |
| Company | Blaine Labs Inc |
| Company location | Santa Fe Springs, CA, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 5,801 bottles |
More recalls from Blaine Labs Inc · all drug recalls · recalls from April 2026