Lidocaine/Racepinephrine Spray Recalled Over Expiration Date Issues

HTO Nevada Inc, doing business as Kirkman, has initiated a voluntary nationwide recall of Five-Star Vasocaine Spray (lidocaine hydrochloride [HCl] 4%, racepinephrine HCl 0.01%), distributed by Dermal Source of Portland, Oregon. The product is packaged in 4-oz bottles and labeled under NDC 80069-016. A total of 27 380 bottles are affected. The recall, initiated on February 18, 2026, remains ongoing and was communicated to consignees via email. The product was distributed nationwide within the US. No press release has been issued.

The recall applies to 9 lots: 839CP-0016, 839CP-0017, 839CP-0018, 839CP-0019, 839CP-0020, 839CP-0021, 839CP-0022, 839CP-0023, and 839CP-0024. The US Food and Drug Administration (FDA) has not yet classified the recall. The firm has not provided a recall number, and a center classification date has not been assigned.

According to the FDA Enforcement Report (event ID 98494), the reason for the recall is that stability data do not support the labeled expiry date. This raises concerns regarding the product’s potency and effectiveness through the stated shelf life.

Five-Star Vasocaine Spray contains lidocaine hydrochloride, a local anesthetic used to temporarily relieve pain and discomfort, and racepinephrine hydrochloride, a vasoconstrictor that reduces swelling. The combination product is generally indicated for temporary relief of pain and minor swelling of mucous membranes, often in dermatologic or minor procedural settings.

Reference

FDA. Enforcement Report. February 18, 2026. Accessed March 5, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=218912