FDA (Drugs) recall action 95427
The FDA (Drugs) publishes a recall like this one as 10 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 10 pages.
cGMP violations
CGMP violations
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Fresenius Kabi Compounding recalled phenylephrine HCl injectable due to cGMP violations. The recall affects 2,756 doses distributed to 125 direct accounts nationwide.
Fresenius Kabi Compounding recalled 1,631 bags of Phenylephrine HCl injection due to manufacturing process violations. The product was distributed to 125 healthcare facilities nationwide. The recall was concluded in August 2025.
Fresenius Kabi Compounding recalled 1,008 bags of Thiamine HCl injectable due to current good manufacturing practice violations. The recall was voluntary and nationwide distribution affected 125 accounts.
Fresenius Kabi is recalling 1,378 bags of phenylephrine HCl injection due to manufacturing violations. The recall affects 125 healthcare facilities nationwide.
Fresenius Kabi Compounding is recalling NORepinephrine Bitartrate injection due to manufacturing violations. The affected medication was distributed to 125 accounts nationwide. Healthcare providers using this product should contact their supplier.
Fresenius Kabi Compounding recalled epinephrine 0.9% sodium chloride injections due to current good manufacturing practice violations. The recall affecting 753 bags distributed to 125 healthcare accounts was terminated on August 15, 2025.
Fresenius Kabi Compounding is voluntarily recalling over 4,400 bags of Oxytocin 0.9% Sodium Chloride Injection due to current Good Manufacturing Practice violations. No illnesses have been reported.
Fresenius Kabi Compounding recalls 2,151 bags of NORepinephrine Bitartrate injectable due to manufacturing violations. The voluntary recall affects 125 healthcare accounts nationwide.
Fresenius Kabi Compounding is recalling Vancomycin HCl injectable medication due to cGMP manufacturing violations. The recall affects 1,082 bags distributed to 125 healthcare accounts nationwide.
Fresenius Kabi Compounding is recalling phenylephrine HCl injection bags due to manufacturing quality violations. The recall affects 1,313 bags distributed to 125 healthcare accounts.