CLASS II ONGOING Drug recall · Reported 15 Apr 2026 · FDA Enforcement Report

norepinephrine Bitartrate,16mg per 0.9% Sodium Chloride recalled

Fagron Compounding Services is recalling norepinephrine Bitartrate,16mg per 0.9% Sodium Chloride Injection USP, Fagron Sterile, distributed nationwide in the US. The recall was initiated on 20 Mar 2026 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot: 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.

Quantity recalled25,260 bags

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0438-2026
FDA event ID: 98636
Recalling firm: Fagron Compounding Services, Wichita, KS
Classification: Class II
Status: Ongoing
Recall initiated: 20 Mar 2026
FDA classified: 7 Apr 2026
Reported: 15 Apr 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Sterility
Drug class: Allergy Medication

Timeline

20 Mar 2026	Recall initiated by company
7 Apr 2026	Classified by FDA	+18 days
15 Apr 2026	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

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

A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.

Product as listed by the FDA

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

Where it was distributed

Nationwide in the U.S.A.

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

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.

Where was it sold?

Nationwide in the U.S.A.

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

4 other products · FDA event 98636

This product is part of a recall event; the main page for the event is Vancomycin HCI added to, 0.9% Sodium Chloride Injection recalled.

Reported	Class	Recall	Company	Reason	Where
15 Apr 2026	CLASS II	Vancomycin HCI added to, 0.9% Sodium Chloride Injection recalled	Fagron Compounding Services	Sterility	Nationwide
15 Apr 2026	CLASS II	Vancomycin HCI added to, 0.9% Sodium Chloride Injection recalled	Fagron Compounding Services	Sterility	Nationwide
15 Apr 2026	CLASS II	norepinephrine Bitartrate, 32mg per 0.9% Sodium Chloride recalled	Fagron Compounding Services	Sterility	Nationwide
15 Apr 2026	CLASS II	Vancomycin HCL added to, 0.9% Sodium Chloride Injection recalled	Fagron Compounding Services	Sterility	Nationwide

More recalls from Fagron Compounding Services

All 13

Reported	Class	Recall	Company	Reason	Where
15 Apr 2026Drug	CLASS II	Vancomycin HCL added to, 0.9% Sodium Chloride Injection recalled	Fagron Compounding Services	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	norepinephrine Bitartrate, 32mg per 0.9% Sodium Chloride recalled	Fagron Compounding Services	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	Vancomycin HCI added to, 0.9% Sodium Chloride Injection recalled	Fagron Compounding Services	Sterility	Nationwide
15 Apr 2026Drug	CLASS II	Vancomycin HCI added to, 0.9% Sodium Chloride Injection recalled	Fagron Compounding Services	Sterility	Nationwide
17 Dec 2025Drug	CLASS II	Tropicamide 1%/Cyclopentolate 1%/Phenylephrine recalled	Fagron Compounding Services	Packaging Defects	Nationwide

Other Norepinephrine Bitartrate recalls

All 21

Reported	Class	Recall	Company	Reason	Where
15 Apr 2026Drug	CLASS II	norepinephrine Bitartrate, 32mg per 0.9% Sodium Chloride recalled	Fagron Compounding Services	Sterility	Nationwide
28 Feb 2024Drug	CLASS II	Norepinephrine Bitartrate in 5% Dextrose Injection, 8 mg recalledNorepinephrine Bitartrate	Baxter Healthcare	Packaging Defects	Nationwide
19 Apr 2023Drug	CLASS III	Norepinephrine Bitartrate Injection, USP, 4 mg/* recalled	SUN Pharmaceutical Industries	Potency & Assay	Nationwide
8 Mar 2023Drug	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide
8 Mar 2023Drug	CLASS II	Norepinephrine Bitartrate in 0.9% Sodium Chloride Injection recalled	Nephron Sterile Compounding Center	Sterility	Nationwide