Fagron Vancomycin Recall, 16,130 Bags, Sterility Issue
Summary
FDA has classified a voluntary Class II recall of Vancomycin HCI 1.5g/250mL 0.9% Sodium Chloride Injection USP (NDC 71266-5085-01) initiated by Fagron Compounding Services of Wichita, KS. The recall affects 16,130 bags across nine lots distributed nationwide. The reason for recall is lack of assurance of sterility combined with a risk that the blue Break-Off-Part could detach from the administration port. The recall was firm-initiated on March 20, 2026 and FDA classified it on April 7, 2026.
“Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01”
What changed
FDA classified a voluntary Class II recall of Vancomycin HCI injection from Fagron Compounding Services. The recall was initiated due to lack of assurance of sterility and a defect where the blue Break-Off-Part could detach from the administration port, affecting nine lots of product totaling 16,130 bags.
Healthcare providers and facilities that have received or administered this product should verify their inventory against the affected lot numbers (C274-000050858 through C274-000051056 with expiration dates from April 2026 through July 2026) and follow the firm's notification procedures. Pharmacies and clinical staff should check stock and quarantine any matching lots pending further guidance from Fagron or FDA.
Archived snapshot
Apr 20, 2026GovPing captured this document from the original source. If the source has since changed or been removed, this is the text as it existed at that time.
Fagron Compounding Services
Drug Recalls (Class II)
← All Drug Recalls (Class II) Class II D-0441-2026 · 20260415 · Ongoing · Voluntary: Firm initiated
Product
Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01
Reason for Recall
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Affected Lot Numbers / Codes
Lot: C274-000050858, Exp.:7/6/2026; C274-000051018, Exp.: 7/13/2026; C274-000049194, Exp.: 4/20/2026; C274-000049591, Exp.: 5/9/2026; C274-000049592, Exp.: 5/9/2026; C274-000049823, Exp.: 5/18/2026; C274-000050301, Exp.: 6/8/2026; C274-000050411, Exp.: 6/13/2026; C274-000051056, Exp.:7/18/2026.
Quantity
16,130 bags
Firm Notification Method
Letter
Distribution
Nationwide in the U.S.A.
Initiated
20260320
FDA Classified
20260407
Related changes
Get daily alerts for FDA Drug Recalls (Class II)
Daily digest delivered to your inbox.
Free. Unsubscribe anytime.
Source
About this page
Every important government, regulator, and court update from around the world. One place. Real-time. Free. Our mission
Source document text, dates, docket IDs, and authority are extracted directly from FDA.
The summary, classification, recommended actions, deadlines, and penalty information are AI-generated from the original text and may contain errors. Always verify against the source document.
Classification
Who this affects
Taxonomy
Browse Categories
Get alerts for this source
We'll email you when FDA Drug Recalls (Class II) publishes new changes.
Subscribed!
Optional. Filters your digest to exactly the updates that matter to you.