FDA-Drug2026-04-15Class IIPROCESSING DEFECT

Fagron norepinephrine injection recalled for sterility concerns and port defect

OTHERPLASTICNationwide distribution

Do not use Fagron norepinephrine injection

Fagron Compounding Services is recalling specific lots of norepinephrine bitartrate injection due to two concerns: the product may not be sterile, and a blue plastic piece on the administration port could detach during use. This medication is used in hospitals and clinical settings to support blood pressure in critically ill patients.

  • If you work in a hospital or clinic, check your inventory against the affected lot numbers (C274-000049934 through C274-000051343, with expiration dates between April 2026 and June 2026).
  • Do not use any vials from the recalled lots.
  • Contact your pharmacy or supplier to return or dispose of affected vials.
  • Contact Fagron immediately if you have questions about your specific inventory.
Hazard

Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

Sold states
Nationwide in the U.S.A.
Affected count
25,260 bags
Manufactured in
8710 E 34th St N, Wichita, KS, United States
Products
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0438-2026

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