FIVE-STAR — Class II drug recall D-0385-2026
Ongoing recall by HTO Nevada Inc. dba Kirkman, reported 2026-03-11, distributed nationwide. Stability Data Does Not Support Expiry Date.
| Recall number | D-0385-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | HTO Nevada Inc. dba Kirkman, Lake Oswego, OR, United States |
| Recall initiated | 2026-02-18 |
| Classified | 2026-03-05 |
| Reported by FDA | 2026-03-11 |
| Distributed | Nationwide (US) |
| Quantity | 27,380 bottles |
| Reason classes | specification failure |
| Lot numbers | 839CP-0016, 839CP-0017, 839CP-0018, 839CP-0019, 839CP-0020, 839CP-0021, 839CP-0022, 839CP-0023, 839CP-0024 |
| Expiration dates | 2026-03-31, 2026-06-30, 2026-08-31, 2026-10-31, 2027-03-31, 2027-07-31, 2027-11-30, 2028-02-29, 2028-07-31 |
Product
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
Reason for recall
Stability Data Does Not Support Expiry Date.
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-0385-2026. 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.