FDA Drugs recall ·
TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles… recall
- Recall number
- D-0695-2026
- Date
- (initiated April 8, 2026)
- Company / brand
- Blaine Labs Inc
11037 Lockport Pl, Santa Fe Springs, CA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 22,143 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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.
Why was it recalled?
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lots BL3431R, Exp Date 10/13/26 & BL3528, Exp Date 08/30/2027.
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0695-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.