Why it was recalled
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Product description
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
Lot numbers, UPCs & expiration codes
Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0697-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Apr 8, 2026
- FDA report date
- Jul 8, 2026
- Quantity
- 5,801 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Blaine Labs Inc
Original FDA data
Every field from FDA enforcement report D-0697-2026, exactly as published.
Show all FDA fields
- City
- Santa Fe Springs
- State
- CA
- Status
- Ongoing
- Country
- United States
- Event ID
- 98731
- Address
- 11037 Lockport Pl
- Code information
- Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027.
- Postal code
- 90670-4634
- Report date
- Jul 8, 2026
- Product type
- Drugs
- Recall number
- D-0697-2026
- Classification
- Class II
- Recalling firm
- Blaine Labs Inc
- Product quantity
- 5,801 bottles
- Reason for recall
- CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Apr 8, 2026
- Initial firm notification
- Press Release
- Center classification date
- Jul 16, 2026