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FDA shortage status: Epinephrine Bitartrate, Lidocaine Hydrochloride Injection

FDA shortage status · Source checked 2026-10-06T18:55:41+00:00

FDA source answer

FDA currently lists this ingredient in shortage.

FDA source statuses: Current. First FDA posting: 2012-02-22. Latest FDA row update: 2026-09-22.

FDA lists 22 package records, with companies: Fresenius Kabi USA, LLC, Hospira, Inc., a Pfizer Company. Package NDCs: 0409-1209-01, 0409-3177-01, 0409-3178-01, 0409-3178-02, 0409-3178-03, 0409-3181-01, 0409-3182-01, 0409-3182-02, 0409-3182-03, 0409-3183-01, 63323-481-57, 63323-482-17, 63323-482-27, 63323-482-57, 63323-483-27, 63323-483-57, 63323-487-17, 63323-487-37, 63323-488-17, 63323-488-37, 63323-489-17, 63323-489-27.

FDA shortage reason: Demand increase for the drug; Other

This is nationwide FDA status, not local pharmacy inventory. CiteFacts does not provide medical, treatment, substitution, or dosing advice.

FDA package and manufacturer records

CompanyPackage NDCPresentationFDA availability fieldFDA update
Fresenius Kabi USA, LLC63323-487-17Xylocaine, Injection, .005 mg/1 mL; 10 mg/1 mL (NDC 63323-487-17)Available2026-09-15
Fresenius Kabi USA, LLC63323-487-37Xylocaine, Injection, .005 mg/1 mL; 10 mg/1 mL (NDC 63323-487-37)Available2026-09-15
Fresenius Kabi USA, LLC63323-488-17Xylocaine, Injection, .005 mg/1 mL; 15 mg/1 mL (NDC 63323-488-17)Unavailable2026-09-15
Fresenius Kabi USA, LLC63323-488-37Xylocaine, Injection, .005 mg/1 mL; 15 mg/1 mL (NDC 63323-488-37)Available2026-09-15
Fresenius Kabi USA, LLC63323-489-17Xylocaine, Injection, .005 mg/1 mL; 20 mg/1 mL (NDC 63323-489-17)Available2026-09-15
Fresenius Kabi USA, LLC63323-489-27Xylocaine, Injection, .005 mg/1 mL; 20 mg/1 mL (NDC 63323-489-27)Unavailable2026-09-15
Fresenius Kabi USA, LLC63323-481-57Xylocaine, Injection, .005 mg/1 mL; 5 mg/1 mL (NDC 63323-481-57)Unavailable2026-09-15
Fresenius Kabi USA, LLC63323-482-17Xylocaine, Injection, .01 mg/1 mL; 10 mg/1 mL (NDC 63323-482-17)Available2026-09-15
Fresenius Kabi USA, LLC63323-482-27Xylocaine, Injection, .01 mg/1 mL; 10 mg/1 mL (NDC 63323-482-27)Available2026-09-15
Fresenius Kabi USA, LLC63323-482-57Xylocaine, Injection, .01 mg/1 mL; 10 mg/1 mL (NDC 63323-482-57)Unavailable2026-09-15
Fresenius Kabi USA, LLC63323-483-27Xylocaine, Injection, .01 mg/1 mL; 20 mg/1 mL (NDC 63323-483-27)Available2026-09-15
Fresenius Kabi USA, LLC63323-483-57Xylocaine, Injection, .01 mg/1 mL; 20 mg/1 mL (NDC 63323-483-57)Available2026-09-15
Hospira, Inc., a Pfizer Company0409-3182-03Lidocaine Hydrochloride And Epinephrine, Injection, 1 g/50 mL (2%; 1:100,000) (NDC 0409-3182-03)Limited Availability2026-09-22
Hospira, Inc., a Pfizer Company0409-3178-01Lidocaine Hydrochloride And Epinephrine, Injection, 200 mg/20 mL (1%; 1:100,000) (NDC 0409-3178-01)Unavailable2026-09-22
Hospira, Inc., a Pfizer Company0409-3177-01Lidocaine Hydrochloride And Epinephrine, Injection, 250 mg/50 mL (0.5%; 1:200,000) (NDC 0409-3177-01)Unavailable2026-09-22
Hospira, Inc., a Pfizer Company0409-3178-02Lidocaine Hydrochloride And Epinephrine, Injection, 300 mg/30 mL (1%; 1:100,000) (NDC 0409-3178-02)Unavailable2026-09-22
Hospira, Inc., a Pfizer Company0409-3182-01Lidocaine Hydrochloride And Epinephrine, Injection, 400 mg/20 mL (2%; 1:100,000) (NDC 0409-3182-01)Unavailable2026-09-22
Hospira, Inc., a Pfizer Company0409-3183-01Lidocaine Hydrochloride And Epinephrine, Injection, 400 mg/20 mL (2%; 1:200,000) (NDC 0409-3183-01)Available2026-09-22
Hospira, Inc., a Pfizer Company0409-3181-01Lidocaine Hydrochloride And Epinephrine, Injection, 450 mg/30 mL (1.5%; 1:200,000) (NDC 0409-3181-01)Available2026-09-22
Hospira, Inc., a Pfizer Company0409-3178-03Lidocaine Hydrochloride And Epinephrine, Injection, 500 mg/50 mL (1%; 1:100,000) (NDC 0409-3178-03)Limited Availability2026-09-22
Hospira, Inc., a Pfizer Company0409-1209-01Lidocaine Hydrochloride And Epinephrine, Injection, 75 mg/5 mL (1.5%; 1:200,000) (NDC 0409-1209-01)Unavailable2026-09-22
Hospira, Inc., a Pfizer Company0409-3182-02Lidocaine Hydrochloride and Epinephrine, Injection, 600 mg/30 mL (2%; 1:100,000) (NDC 0409-3182-02)Limited Availability2026-09-22

Source facts

Grouped generic ingredient: Epinephrine Bitartrate, Lidocaine Hydrochloride Injection · 22 package records

Therapeutic categories: Anesthesia, Pediatric
Dosage forms: Injection
Routes: EPIDURAL, INFILTRATION, INTRACAUDAL, PERINEURAL

Open FDA source data · JSON · Markdown

FDA is authoritative. Source retrieved 2026-10-06T18:55:41+00:00. Derived grouping is documented in this record's derivations.