Epinephrine Bitartrate and Lidocaine Hydrochloride Injection Shortage: Availability Updates for Xylocaine
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The FDA reports a current shortage affecting specific presentations of Epinephrine Bitartrate and Lidocaine Hydrochloride Injection, with some supplies expected to return in February 2026.
What this FDA drug-shortage notice tells you, and what most readers miss
This notice was issued by FDA on February 11, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — Drug Shortages — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.
Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA drug-shortage notice is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.
For decision-making, Areazine pairs each alert with the original agency URL, the full agency name, and a timestamp so you can verify the notice against the primary source before acting on it. Tags on this item (drug-shortage, fda, medication, Epinephrine-Bitartrate) map to related alerts in the same area of risk — browsing them together gives a clearer picture than any single notice alone, because the shape of an ongoing issue only becomes visible across multiple sequential alerts.
What's in Shortage
There is a current shortage of Epinephrine Bitartrate and Lidocaine Hydrochloride Injection, commonly known by the brand names XYLOCAINE and XYLOCAINE MPF. This medication is an injection used primarily in Anesthesia and Pediatric therapeutic categories.
The shortage was first posted on October 14, 2016, and the most recent update was provided on February 5, 2026.
Which Manufacturers Are Affected
Fresenius Kabi USA, LLC is the manufacturer currently reporting availability issues for specific presentations. While many versions remain available, several are currently backordered.
Manufacturer Contact: 888-386-1300
Unavailable Presentations:
- Xylocaine, Injection, .01 mg/1 mL; 10 mg/1 mL (NDC 63323-482-17): Next release expected February 2026.
- Xylocaine, Injection, .005 mg/1 mL; 20 mg/1 mL (NDC 63323-489-17): Next release expected February 2026.
- Xylocaine, Injection, .005 mg/1 mL; 10 mg/1 mL (NDC 63323-487-17): Next release expected February 2026.
Available Presentations:
- Xylocaine, Injection, .005 mg/1 mL; 15 mg/1 mL (NDC 63323-488-37)
- Xylocaine, Injection, .005 mg/1 mL; 10 mg/1 mL (NDC 63323-487-37)
- Xylocaine, Injection, .005 mg/1 mL; 15 mg/1 mL (NDC 63323-488-17)
- Xylocaine, Injection, .01 mg/1 mL; 10 mg/1 mL (NDC 63323-482-57)
- Xylocaine, Injection, .01 mg/1 mL; 10 mg/1 mL (NDC 63323-482-27)
- Xylocaine, Injection, .01 mg/1 mL; 20 mg/1 mL (NDC 63323-483-27)
- Xylocaine, Injection, .005 mg/1 mL; 20 mg/1 mL (NDC 63323-489-27)
- Xylocaine, Injection, .01 mg/1 mL; 20 mg/1 mL (NDC 63323-483-57)
- Xylocaine, Injection, .005 mg/1 mL; 5 mg/1 mL (NDC 63323-481-57)
Note: The manufacturer advises checking with wholesalers for current inventory.
Why There's a Shortage
The source data does not provide a specific reason for the current shortage of these presentations.
What Patients Should Do
If you or a family member are scheduled for a procedure requiring this medication, please consider the following steps:
- Consult Your Healthcare Provider: Discuss the availability of this medication with your doctor or surgeon. They can determine if an available presentation or an alternative treatment is appropriate for your care.
- Speak with Your Pharmacist: Pharmacists often have the most up-to-date information regarding local stock and wholesaler availability.
- Contact the Manufacturer: For specific questions regarding supply timelines, you may contact Fresenius Kabi USA, LLC at 888-386-1300.
Disclaimer: Patients should always consult their healthcare provider regarding medication changes or treatment options.
Source
Information provided by the FDA Drug Shortage Database.
Original source: FDA Official Notice ↗
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