FDA Drug recall D-0694-2026
TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio,…
- FDA Drug
- Class II
- ongoing
- Published 2026-07-08
On 2026-07-08 the FDA classified a Class II recall of TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio,… 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-0694-2026 |
| 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
TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%), 1.25 FL OZ (37.5 mL) bottle, Manufactured For: Trifluent Pharma, LLC, San Antonio, TX 78213, NDC 73352-550-01.
Reason
CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry
Identifiers
| ndc | 73352-550-01 |
|---|---|
| code_info | Lot #BL3411R, Exp 6/8/2027 |
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-0694-2026%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.