Vancomycin HCI Recall - Class II, Sterility Concerns, Fagron Compounding Services
Summary
Fagron Compounding Services voluntarily recalled Vancomycin HCI 1.25g/250mL 0.9% Sodium Chloride Injection USP (NDC 71266-5083-01) due to lack of assurance of sterility and a potential detachment risk from the blue Break-Off-Part on the administration port. The recall covers 18 lots totaling 34,260 bags with expiration dates from April through July 2026 and was initiated firm-wide on March 20, 2026, with FDA Class II classification on April 7, 2026.
“Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01”
What changed
Fagron Compounding Services initiated a Class II drug recall for Vancomycin HCI sterile injection products due to two quality concerns: lack of sterility assurance and the potential for the blue Break-Off-Part to detach from the administration port. The recall encompasses 18 lot numbers distributed nationwide, representing a significant volume of compounded sterile preparations.
Healthcare providers and patients should immediately identify and quarantine any affected lots in their inventory. Pharmacies and healthcare facilities utilizing this Vancomycin preparation should verify their supply chain against the listed lot numbers and expiration dates, and contact Fagron Sterile Services for return instructions. The voluntary nature of this recall indicates the firm identified the risk proactively, though the scope across 18 lots suggests a systemic manufacturing or quality control issue warranting heightened supplier vigilance.
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-0440-2026 · 20260415 · Ongoing · Voluntary: Firm initiated
Product
Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01
Reason for Recall
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Affected Lot Numbers / Codes
Lot: C274-000050857, Exp.:7/6/2026; C274-000049316, Exp.: 4/26/2026; C274-000049367, Exp.: 4/28/2026; C274-000049496, Exp.: 5/3/2026; C274-000049518, Exp.: 5/4/2026; C274-000049535, Exp.: 5/5/2026; C274-000049653, Exp.: 5/11/2026; C274-000049654, Exp.: 5/11/2026; C274-000049745, Exp.: 5/16/2026; C274-000050128, Exp.: 5/31/2026; C274-000050151, Exp.: 6/1/2026; C274-000050184, Exp.: 6/6/2026; C274-000050504, Exp.: 6/15/2026; C274-000050662, Exp.: 6/21/2026; C274-000050836, Exp.: 7/5/2026; C274-000051014, Exp.: 7/13/2026; C274-000051057, Exp.: 7/18/2026; C274-000051240, Exp.: 7/25/2026.
Quantity
34,260 bags
Firm Notification Method
Letter
Distribution
Nationwide in the U.S.A.
Initiated
20260320
FDA Classified
20260407
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