Kirkman FIVE-STAR VASOCAINE Spray recalled due to unstable expiry dates
Kirkman's FIVE-STAR VASOCAINE Spray (a local anesthetic spray) is being recalled because the manufacturer's stability testing does not support the printed expiration dates on the bottles. This means the product may degrade or become less effective before the labeled date. Nine lots distributed nationwide are affected, with expiration dates ranging from March 2026 to July 2028.
From the FDA notice · Read the official notice ↗
What to do
- Check if you have any bottles of Kirkman FIVE-STAR VASOCAINE Spray with lot numbers 839CP-0016 through 839CP-0024.
- Stop using any affected bottles immediately.
- Consult your doctor or pharmacist about whether you need a replacement or alternative anesthetic spray.
- Contact Dermal Source (distributor) or the manufacturer for return instructions.
Is yours affected?
Compare your label or packaging with the recalled product.
- Product
- FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016.
- Sold in
- Nationwide
- Made for
- All ages (0 months and older)
This recall covers 3 products — see all of them.
Details
- Units affected
- 27,380 bottles.
- Illnesses reported
- None reported
- Manufactured in
- 6400 Rosewood St, N/A, Lake Oswego, OR, United States
- Classification
- Class II
- Recall number
- D-0385-2026
In the FDA's words
- Description
- FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016. Stability Data Does Not Support Expiry Date. 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. Distribution: Nationwide within the U.S Affected quantity: 27,380 bottles.
- Hazard
- Stability Data Does Not Support Expiry Date.
3 products in this recall
Five-Star Vasocaine and Maximum lidocaine recalled over expiry dates
Kirkman is recalling three topical numbing products, distributed by Dermal Source of Portland, OR: Five-Star Vasocaine spray, Maximum Zone 1 lidocaine cream, and Maximum Zone 2 lidocaine cream. The company's stability testing does not support the expiry dates printed on these products. No injuries have been reported.
The agency lists each product separately. Check every one you might have.
- FIVE-STAR, VASOCAINE Spray, (Lidocaine HCl 4%, Racepinephrine HCl 0.01%), 4oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-016. (this page)D-0385-2026 · 27,380 bottles.
- MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-014.D-0386-2026 · 178 bottles
- MAXIMUM, ZONE 2, 4% Lidocaine Cream, (Lidocaine 4% and Epinephrine 0.01%), 1 oz bottles, Distributed By: Dermal Source, Portland, OR 97232, NDC 80069-015.D-0387-2026 · 243 bottles