FDA Recall of Norepinephrine Bitartrate Injection by Fagron Compounding Services

Source: FDA · United States

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The FDA has announced a recall of norepinephrine Bitartrate injection due to concerns over sterility and potential detachment of a part, affecting 5140 bags distributed nationwide.

What this FDA recall tells you, and what most readers miss

This notice was issued by FDA on April 22, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken - "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to - FDA Recalls - determines the consumer-protection framework behind it, which shapes what remedies (refunds, replacements, repairs, or the recall itself) are available to affected consumers and which agency holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action, a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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FDA Recall of Norepinephrine Bitartrate Injection

What Happened

Fagron Compounding Services is recalling the product due to a lack of assurance of sterility and the possibility that the blue break-off part could detach from the administration port.

Which Products Are Affected

The affected product is norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, with NDC 71266-5027-02. The recall involves 5140 bags from the following lots: C274-000050004 (expiration 4/24/2026), C274-000050295 (expiration 5/8/2026), C274-000051773 (expiration 6/4/2026), C274-000051219 (expiration 6/21/2026), C274-000051318 (expiration 6/27/2026), and C274-000051602 (expiration 7/12/2026). The product was distributed nationwide in the U.S.A., with the recall number D-0439-2026.

What You Should Do

Consumers should follow the initial firm notification, which was a letter, and contact Fagron Compounding Services at their address: 8710 E 34th St N, Wichita, KS 67226-2636, for information on returns or further instructions.

Why This Matters

This recall addresses potential risks associated with drug sterility, which could impact patient safety in medical settings, highlighting the importance of quality assurance in pharmaceutical products.

Source

Attribution: FDA Recall Notice D-0439-2026. For more information, visit the FDA website.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
The FDA has announced a recall of norepinephrine Bitartrate injection due to concerns over sterility and potential detachment of a part, affecting 5140 bags distributed nationwide.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more FDA Recalls updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.