FDA Drug Regulatory Intelligence

Shortage: Epinephrine Bitartrate, Lidocaine Hydrochloride Injection

This page indexes a United States Food and Drug Administration (FDA) drug-shortage record for Epinephrine Bitartrate, Lidocaine Hydrochloride Injection. The record is reported by Fresenius Kabi Usa, LLC and currently carries a regulatory status of Current. A drug-shortage entry of this kind is an administrative supply-status record that the FDA maintains and publishes for transparency and reference. This entry names the affected product as Epinephrine Bitartrate, Lidocaine Hydrochloride Injection, attributes the report to the company shown above, and records a status of Current marking where the shortage sits within the agency's public tracking lifecycle at the time it was ingested by this site. The affected presentation is described in the source as Xylocaine, Injection, .005 mg/1 mL; 15 mg/1 mL (NDC 63323-488-37). The availability field published by the FDA reads: Available. This shortage record was published on 2026-06-04. It was first posted on 2016-10-14. All values shown here are reproduced as regulatory data points from the official FDA drug-shortages dataset to help you find and verify the original entry. This page does not advise on therapeutic substitution, does not assess clinical impact, and is not a recommendation of any kind. Verify the current status against the linked FDA source.

FDA shortage data

Generic name Epinephrine Bitartrate, Lidocaine Hydrochloride Injection
Status Current
Presentation Xylocaine, Injection, .005 mg/1 mL; 15 mg/1 mL (NDC 63323-488-37)
Availability (source text) Available
Reporting company Fresenius Kabi Usa, LLC
Related information Check wholesalers for inventory
Initial posting date 2016-10-14
Last updated date 2026-06-04

How to interpret this shortage record

A drug-shortage record means the FDA has logged a reported supply constraint for a product as part of its public shortage tracking. The status (Current) describes where the shortage sits in its lifecycle according to the agency's data. A shortage entry is an administrative supply signal — it does not describe the clinical role of the product, does not suggest any substitute, and does not indicate that any specific patient is affected. Read this entry as a pointer to the official FDA shortage listing and confirm the live status there before relying on it.

What this record does not mean

This shortage record does not constitute medical advice and does not tell you whether to start, stop, switch, or avoid any product. It does not assess safety for any individual, does not provide dosage, treatment, or therapeutic guidance, and does not diagnose any condition. The dataset is coverage-limited: it reflects what the FDA has published in the indexed source at ingestion time, which may lag the live record and may omit details held only in primary documents. For any health decision, consult a qualified healthcare professional, and for the authoritative record consult the FDA directly through the linked official source.

Related manufacturer

This shortage is reported by Fresenius Kabi Usa, LLC. That page aggregates the firm's other indexed records as coverage-limited regulatory signals (not quality ratings).

Related shortages (Current)

Source & provenance

Official source
https://www.accessdata.fda.gov/scripts/drugshortages/
Source dataset
openFDA Drug Shortages API
Publication date
2016-10-14
Ingested
2026-06-09
Record hash
99cd494e7ee32327

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.