Fagron Compounding Services Recalls Norepinephrine Bitartrate Injection Due to Sterility and Component Issues
Summary
FDA classified a Class II voluntary recall by Fagron Compounding Services for 25,260 bags of Norepinephrine Bitartrate Injection due to lack of assurance of sterility and a potential defect where the blue Break-Off-Part could detach from the administration port. The recall affects 14 lot numbers with expiration dates from April 23, 2026 through June 28, 2026 and was distributed nationwide in the United States. The firm initiated the recall on March 20, 2026.
What changed
Fagron Compounding Services initiated a voluntary Class II recall affecting 14 lots of norepinephrine bitartrate injection totaling 25,260 bags. The recall was triggered by two product quality concerns: lack of assurance of sterility and a mechanical defect where the blue Break-Off-Part could detach from the administration port. FDA classified this as a Class II recall on April 7, 2026.\n\nHealthcare providers and facilities that received these lots should verify their inventory against the 14 affected lot numbers and suspend use pending further guidance. Pharmacies and clinical settings compounding or administering this product should quarantine affected stock and contact Fagron through the notification letter for return instructions.
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-0438-2026 · 20260415 · Ongoing · Voluntary: Firm initiated
Product
norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02
Reason for Recall
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Affected Lot Numbers / Codes
Lot: C274-000049934, Exp.: 4/23/2026; C274-000049963, Exp.:4/24/2026; C274-000050074, Exp.: 4/30/2026; C274-000050123, Exp.:5/1/2026; C274-000050296, Exp.: 5/9/2026; C274-000050420, Exp.: 5/16/2026; C274-000050774, Exp.:6/5/2026; C274-000050924, 6/7/2026; C274-000050961, Exp.: 6/11/2026; C274-000050991, Exp.: 6/12/2026; C274-000051139, Exp.:6/19/2026; C274-000051166, Exp.:6/20/2026; C274-000051198, Exp.:6/21/2026; C274-000051343, Exp.:6/28/2026.
Quantity
25,260 bags
Firm Notification Method
Letter
Distribution
Nationwide in the U.S.A.
Initiated
20260320
FDA Classified
20260407
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