Serious riskFDA DrugClass II

Fagron norepinephrine injection recalled for sterility concerns and port defect

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.

From the FDA notice · Read the official notice ↗

What to do

  1. 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).
  2. Do not use any vials from the recalled lots.
  3. Contact your pharmacy or supplier to return or dispose of affected vials.
  4. Contact Fagron immediately if you have questions about your specific inventory.

Is yours affected?

Compare your label or packaging with the recalled product.

Product
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
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 5 products — see all of them.

Details

Units affected
25,260 bags
Illnesses reported
None reported
Manufactured in
8710 E 34th St N, Wichita, KS, United States
Classification
Class II
Recall number
D-0438-2026

In the FDA's words

Description
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 Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port Lot: C274-000049934, Exp.: 4/23/2026; C274-000049963, Exp.:4/24/2026; C274-000050074, Exp.: 4/30/2026; C274-000050123, Exp.:5/1/2026; C274-000050296, Exp.: 5/9/2026; C274-000050420, Exp.: 5/16/2026; C274-000050774, Exp.:6/5/2026; C274-000050924, 6/7/2026; C274-000050961, Exp.: 6/11/2026; C274-000050991, Exp.: 6/12/2026; C274-000051139, Exp.:6/19/2026; C274-000051166, Exp.:6/20/2026; C274-000051198, Exp.:6/21/2026; C274-000051343, Exp.:6/28/2026. Distribution: Nationwide in the U.S.A. Affected quantity: 25,260 bags
Hazard
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port

5 products in this recall

Fagron IV norepinephrine and vancomycin bags recalled for sterility concerns

Fagron Compounding Services is recalling five premixed IV bags in 0.9% sodium chloride: norepinephrine bitartrate (16 mg and 32 mg per 250 mL) and vancomycin (1 g, 1.25 g and 1.5 g per 250 mL). The bags were made by Fagron Sterile Services in Wichita, Kansas, and sold nationwide, and the company cannot assure they are sterile. A blue break-off part on the administration port could also detach. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

Related topics

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