Recall archive / FDA drug enforcement

dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syring... — FDA record D-0371-2025

Reported ongoing

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Mar 31, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: dexmedeTOMIDine HCl PF, in 0.9% Sodium Chloride, 20 mcg (base) per 5mL, (4 mcg (base) per mL), 5mL Single Dose syringe, Rx only, Leiters Health, 13796 Compark Blvd, Englewood, CO 80112, NDC: 71449-131-11.
Reason: Lack of Assurance of Sterility: Leaking/damaged syringes.
Classification: Class II
Recalling firm: Denver Solutions, LLC DBA Leiters Health
Quantity: 23,610 syringes
Agency-reported status: Ongoing
Source record identifier: D-0371-2025

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot #: 2431276A, Exp.: 4/20/2025

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the U.S.A

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Apr 30, 2025
Recall initiation date: Mar 31, 2025
Center classification date: Apr 18, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.