CLASS II ONGOING Drug recall · Reported 11 Mar 2026 · FDA Enforcement Report
Five-star, Vasocaine Spray, (Lidocaine HCl recalled by HTO Nevada
HTO Nevada is recalling Five-star, Vasocaine Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), distributed nationwide in the US. The recall was initiated on 18 Feb 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0385-2026
- FDA event ID
- 98494
- Recalling firm
- HTO Nevada, Lake Oswego, OR
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Feb 2026
- FDA classified
- 5 Mar 2026
- Reported
- 11 Mar 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 18 Feb 2026 | Recall initiated by company | |
| 5 Mar 2026 | Classified by FDA | +15 days |
| 11 Mar 2026 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stability Data Does Not Support Expiry Date.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
Where it was distributed
Nationwide within the U.S
Questions about this recall
Why was it recalled?
Stability Data Does Not Support Expiry Date.
Which lots are affected?
Lot #: 839CP-0016, Exp. Date 03/31/2026; 839CP-0017, Exp. Date 06/30/2026; 839CP-0018, Exp. Date 08/31/2026; 839CP-0019, Exp. Date 10/31/2026; 839CP-0020, Exp. Date 03/31/2027; 839CP-0021, Exp. Date 07/31/2027; 839CP-0022, Exp.Date 11/30/2027; 839CP-0023, Exp. Date 02/29/2028; 839CP-0024, Exp. Date 07/31/2028.
Where was it sold?
Nationwide within the U.S
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
2 other products · FDA event 98494| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Maximum, Zone 2, 4% Lidocaine Cream, (Lidocaine recalled by HTO Nevada | HTO Nevada | Potency & Assay | Nationwide | |
| CLASS II | Maximum, Zone 1, 4% Lidocaine Cream recalled by HTO Nevada | HTO Nevada | Potency & Assay | Nationwide |
More recalls from HTO Nevada
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Maximum, Zone 1, 4% Lidocaine Cream recalled by HTO Nevada | HTO Nevada | Potency & Assay | Nationwide |
| Drug | CLASS II | Maximum, Zone 2, 4% Lidocaine Cream, (Lidocaine recalled by HTO Nevada | HTO Nevada | Potency & Assay | Nationwide |
| Food | CLASS III | Kirkman brand 5-MTHF Methyltetrahydrofolate 1mg capsule recalledKirkman | HTO Nevada | Labeling Errors | 6 states |
| Drug | CLASS II | New & Improved Blue Gel Anesthetic, to reduce pain recalled | HTO Nevada | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Maximum Zone2 Topical Analgesic recalled by HTO Nevada | HTO Nevada | Manufacturing (CGMP) Deviations | Nationwide |