Fagron Norepinephrine Bitartrate 5140-Bag Class II Recall

Fagron Compounding Services initiated a voluntary Class II recall of norepinephrine Bitartrate 32mg per 250mL 0.9% Sodium Chloride Injection USP (NDC 71266-5027-02) after identifying sterility assurance failures and a potential manufacturing defect where the blue Break-Off-Part could detach from the administration port. The recall covers six lots (C274-000050004 through C274-000051602) totaling 5,140 bags, distributed nationwide. The FDA classified the recall on April 7, 2026, and the recall remains ongoing.

Healthcare providers and facilities that received this product should verify their inventory against the affected lot numbers and follow the firm's notification procedures. While the recall is voluntary, Class II designation indicates temporary or reversible health consequences where use of the affected product may cause serious adverse health consequences or death. Affected parties should monitor for any FDA updates and communicate with Fagron regarding return or destruction of affected stock.