Fagron Compounding Services Issues Recall for Vancomycin HCI Injection

Source: FDA · United States

Areazine synthesizes this FDA recall directly from FDA's official public data feed. See our methodology for full source attribution and refresh cadence.

Fagron Compounding Services is voluntarily recalling 16,130 bags of Vancomycin HCI due to lack of sterility assurance and potential detachment of a blue break-off part, 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 verify its scope, source, and timestamp, then compare related notices without assuming that one record proves a broader trend.

Areazine pairs this record with the original agency URL so you can check the primary source before acting. Its related labels are recall, product-safety, fda, Drugs.

Recall of Vancomycin HCI Injection

What Happened

Fagron Compounding Services is recalling certain lots of Vancomycin HCI 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 HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, with NDC 71266-5085-01. A total of 16,130 bags are involved, distributed nationwide in the U.S.A. The specific lots are: C274-000050858 (expiration: 7/6/2026), C274-000051018 (expiration: 7/13/2026), C274-000049194 (expiration: 4/20/2026), C274-000049591 (expiration: 5/9/2026), C274-000049592 (expiration: 5/9/2026), C274-000049823 (expiration: 5/18/2026), C274-000050301 (expiration: 6/8/2026), C274-000050411 (expiration: 6/13/2026), and C274-000051056 (expiration: 7/18/2026). The recall number is D-0441-2026.

What You Should Do

Consumers should check if they have the affected lots and follow the initial firm notification, which was issued via letter. For returns or refunds, contact Fagron Compounding Services at their address: 8710 E 34th St N, Wichita, KS 67226-2636.

Why This Matters

This recall involves over 16,000 bags of a critical drug distributed across the United States, underscoring potential risks in ensuring the sterility of medical products that could affect patient safety.

Source

FDA recall notice, recall number D-0441-2026

Original source: FDA Official Notice ↗

All FDA Recalls →

Nationwide notices with similar length or severity timing 8

Two Areazine-derived peer sets for this FDA recall: nearest notices by body length and by same severity near the same agency date. Peers come from other categories so they are not the same-feed Related list above.

Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall about?
Fagron Compounding Services is voluntarily recalling 16,130 bags of Vancomycin HCI due to lack of sterility assurance and potential detachment of a blue break-off part, 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.