FDA Drug recall D-0697-2026
TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lock…
- FDA Drug
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of TERPENICOL Antifungal Solution, (Undecylenic (10-Undecenoic) acid 25%), 1.0 Fl Oz (29.6 mL), Manufactured By: Blaine Labs, Inc., 11037 Lock… by Blaine Labs, citing CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0697-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-08 |
| Published | 2026-07-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Blaine Labs |
| Distribution | US |
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
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Identifiers
| ndc | 63347-600-01 |
|---|---|
| code_info | Lots BL3411R, Exp Date 06/08/2027, BL3468, Exp Date 03/07/2027, & BL3535, Exp Date 09/25/2027. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0697-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.