TERPENICOL Antifungal Solution — Class II drug recall D-0697-2026
Ongoing recall by Blaine Labs Inc, reported 2026-07-08, distributed nationwide. CGMP Deviations; the firm discontinued required stability testing for products on the market still within expi
| Recall number | D-0697-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Blaine Labs Inc, Santa Fe Springs, CA, United States |
| Recall initiated | 2026-04-08 |
| Classified | 2026-07-16 |
| Reported by FDA | 2026-07-08 |
| Distributed | Nationwide (US) |
| Quantity | 5,801 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 63347-0600, 63347-0600-01 |
| Lot numbers | BL3411R, BL3468, BL3535 |
| Expiration dates | 2027-03-07, 2027-06-08, 2027-09-25 |
Product
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 for recall
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0697-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.