TERPENICOL Antifungal Cream (Undecylenic Acid 13%) recall
FDA recall D-0695-2026 · initiated Apr 8, 2026
Blaine Labs Inc recalled TERPENICOL Antifungal Cream (Undecylenic Acid 13%) in Apr 2026 — an FDA Class II recall (D-0695-2026) because CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 22,143 bottles
Details
- 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.
- Recalling company
- Blaine Labs Inc
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 8, 2026
- FDA report date
- Jul 8, 2026
Frequently asked
- Was TERPENICOL Antifungal Cream (Undecylenic Acid 13%) recalled?
- Blaine Labs Inc recalled TERPENICOL Antifungal Cream (Undecylenic Acid 13%) in Apr 2026 — an FDA Class II recall (D-0695-2026) because CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was TERPENICOL Antifungal Cream (Undecylenic Acid 13%) recalled?
- Per the FDA enforcement record, the reason for recall D-0695-2026 was: CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
- Is a recalled TERPENICOL Antifungal Cream (Undecylenic Acid 13%) dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of TERPENICOL Antifungal Cream (Undecylenic Acid 13%) are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0695-2026.