Fagron norepinephrine infusion bags recalled over sterility and detaching port part

Plain-English summary

Fagron Compounding Services is recalling norepinephrine bitartrate, 16 mg per 250 mL of 0.9% Sodium Chloride Injection USP, NDC 71266-5026-02. The action covers 25,260 bags.

Two reasons are stated: lack of assurance of sterility, and that the blue break-off part could detach from the administration port. Sterility is a defining requirement of an injectable product, and a detaching component at the administration port affects the integrity of the delivery route. The FDA classified the action as Class II.

Affected lots include C274-000049934 (exp 4/23/2026), C274-000049963 (exp 4/24/2026), C274-000050074 (exp 4/30/2026), C274-000050123 (exp 5/1/2026) and C274-000050296 (exp 5/9/2026), with the full list in the recall notice. Distribution was nationwide in the USA.

This is a compounded prescription product supplied to healthcare facilities. Facilities should check stock against the lot numbers in the recall notice, quarantine affected bags and follow the instructions issued by Fagron.

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

Manufacturer

Fagron Compounding Services

Category

Drug — Compounded injectable

Hazard

• sterility-assurance
• injectable
• component-detachment
• class-ii
• compounded-drug

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Distribution

Distributed nationwide across the United States.

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