Fresenius Kabi Compounding recalls

Fresenius Kabi Compounding has 15 recalls on record with the FDA and USDA, the earliest in 2024 and the latest reported on 18 Feb 2026. 5 are still ongoing. 5 were reported in the last 12 months. The most frequent reason is manufacturing (cgmp) deviations.

Total recalls15since 2024
Last 12 months5reported
Class I00% of total
Ongoing5latest 18 Feb 2026

Recalls per month, last 24 months

click a bar for that month

Severity split

Class I 0 0%Class II 15 100%Class III 0 0%

Why fresenius kabi compounding is recalled

By year

Ongoing fresenius kabi compounding recalls

5 active

All fresenius kabi compounding recalls, newest first

15 total
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIacyclovir sodium, 200 mg, 200mg added recalledFresenius Kabi CompoundingSterilityNationwide
DrugCLASS IIvancomycin HCl added to, 0.9% Sodium Chloride Injection recalledFresenius Kabi CompoundingSterilityNationwide
DrugCLASS IIvancomycin HCl added to, 0.9% Sodium Chloride Injection recalledFresenius Kabi CompoundingSterilityNationwide
DrugCLASS IIketamine HCl, 1,000 mg, 1,000 mg per (10 mg per mL) recalledFresenius Kabi CompoundingSterilityNationwide
DrugCLASS IIthiamine HCl, 500 mg, 500 mg added recalledFresenius Kabi CompoundingSterilityNationwide
DrugCLASS IIPhenylephrine HCl 0.9% Sodium Chloride Injection recalledFresenius Kabi CompoundingManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIPhenylephrine HCl 0.9% Sodium Chloride Injection recalledFresenius Kabi CompoundingManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIVancomycin HCl 750 mg per 0.9% Sodium Chloride Injection recalledFresenius Kabi CompoundingManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIThiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg recalledFresenius Kabi CompoundingManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIPhenylephrine HCl 0.9% Sodium Chloride Injection recalledFresenius Kabi CompoundingManufacturing (CGMP) DeviationsNationwide
DrugCLASS IINORepinephrine Bitartrate 0.9% Sodium Chloride Injection recalledFresenius Kabi CompoundingManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIOxytocin 0.9% Sodium Chloride Injection USP per Single Dose recalledFresenius Kabi CompoundingManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIEPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per Single Dose recalledFresenius Kabi CompoundingManufacturing (CGMP) DeviationsNationwide
DrugCLASS IIPhenylephrine HCl 0.9% Sodium Chloride Injection recalledFresenius Kabi CompoundingManufacturing (CGMP) DeviationsNationwide
DrugCLASS IINORepinephrine Bitartrate 0.9% Sodium Chloride Injection recalledFresenius Kabi CompoundingManufacturing (CGMP) DeviationsNationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.