Recall of Vancomycin HCL Injection by Fagron Compounding Services

Source: FDA · United States

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Fagron Compounding Services is voluntarily recalling 11,680 bags of Vancomycin HCL due to lack of assurance of sterility and potential detachment of a blue part from the administration port, affecting products distributed nationwide in the U.S.

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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What Happened

Fagron Compounding Services is recalling its Vancomycin HCL 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 Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, manufactured by Fagron Sterile Services, with NDC 71266-5082-01. A total of 11,680 bags are involved, distributed nationwide in the U.S.A. The specific lots are: C274-000050987 (Exp. 7/12/2026), C274-000049425 (Exp. 5/2/2026), C274-000050069 (Exp. 5/30/2026), C274-000050346 (Exp. 6/10/2026), C274-000050698 (Exp. 6/27/2026), C274-000050699 (Exp. 6/27/2026), and C274-000050775 (Exp. 7/4/2026). The recall number is D-0442-2026.

What You Should Do

Consumers who have the affected products should follow the initial firm notification, which was issued via letter. Contact Fagron Compounding Services at their address, 8710 E 34th St N, Wichita, KS 67226-2636, for instructions on returns or refunds.

Why This Matters

This recall involves a significant quantity of medication distributed across the United States, highlighting potential risks to patient safety from sterility issues in a drug used for infections.

Source

Attribution: FDA. Recall Number: D-0442-2026.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Fagron Compounding Services is voluntarily recalling 11,680 bags of Vancomycin HCL due to lack of assurance of sterility and potential detachment of a blue part from the administration port, affecting products distributed nationwide in the U.S.
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.