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 recalls 15 since 2024
Last 12 months 5 reported
Class I 0 0% of total
Ongoing 5 latest 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
Ongoing fresenius kabi compounding recalls 5 active
Reported Class Recall Company Reason Where 18 Feb 2026 Drug CLASS II acyclovir sodium, 200 mg, 200mg added recalled Fresenius Kabi Compounding Sterility Nationwide 18 Feb 2026 Drug CLASS II vancomycin HCl added to, 0.9% Sodium Chloride Injection recalled Fresenius Kabi Compounding Sterility Nationwide 18 Feb 2026 Drug CLASS II vancomycin HCl added to, 0.9% Sodium Chloride Injection recalled Fresenius Kabi Compounding Sterility Nationwide 18 Feb 2026 Drug CLASS II ketamine HCl, 1,000 mg, 1,000 mg per (10 mg per mL) recalled Fresenius Kabi Compounding Sterility Nationwide 18 Feb 2026 Drug CLASS II thiamine HCl, 500 mg, 500 mg added recalled Fresenius Kabi Compounding Sterility Nationwide
All fresenius kabi compounding recalls, newest first 15 total
Reported Class Recall Company Reason Where 18 Feb 2026 Drug CLASS II acyclovir sodium, 200 mg, 200mg added recalled Fresenius Kabi Compounding Sterility Nationwide 18 Feb 2026 Drug CLASS II vancomycin HCl added to, 0.9% Sodium Chloride Injection recalled Fresenius Kabi Compounding Sterility Nationwide 18 Feb 2026 Drug CLASS II vancomycin HCl added to, 0.9% Sodium Chloride Injection recalled Fresenius Kabi Compounding Sterility Nationwide 18 Feb 2026 Drug CLASS II ketamine HCl, 1,000 mg, 1,000 mg per (10 mg per mL) recalled Fresenius Kabi Compounding Sterility Nationwide 18 Feb 2026 Drug CLASS II thiamine HCl, 500 mg, 500 mg added recalled Fresenius Kabi Compounding Sterility Nationwide 30 Oct 2024 Drug CLASS II Phenylephrine HCl 0.9% Sodium Chloride Injection recalled Fresenius Kabi Compounding Manufacturing (CGMP) Deviations Nationwide 30 Oct 2024 Drug CLASS II Phenylephrine HCl 0.9% Sodium Chloride Injection recalled Fresenius Kabi Compounding Manufacturing (CGMP) Deviations Nationwide 30 Oct 2024 Drug CLASS II Vancomycin HCl 750 mg per 0.9% Sodium Chloride Injection recalled Fresenius Kabi Compounding Manufacturing (CGMP) Deviations Nationwide 30 Oct 2024 Drug CLASS II Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg recalled Fresenius Kabi Compounding Manufacturing (CGMP) Deviations Nationwide 30 Oct 2024 Drug CLASS II Phenylephrine HCl 0.9% Sodium Chloride Injection recalled Fresenius Kabi Compounding Manufacturing (CGMP) Deviations Nationwide 30 Oct 2024 Drug CLASS II NORepinephrine Bitartrate 0.9% Sodium Chloride Injection recalled Fresenius Kabi Compounding Manufacturing (CGMP) Deviations Nationwide 30 Oct 2024 Drug CLASS II Oxytocin 0.9% Sodium Chloride Injection USP per Single Dose recalled Fresenius Kabi Compounding Manufacturing (CGMP) Deviations Nationwide 30 Oct 2024 Drug CLASS II EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per Single Dose recalled Fresenius Kabi Compounding Manufacturing (CGMP) Deviations Nationwide 30 Oct 2024 Drug CLASS II Phenylephrine HCl 0.9% Sodium Chloride Injection recalled Fresenius Kabi Compounding Manufacturing (CGMP) Deviations Nationwide 30 Oct 2024 Drug CLASS II NORepinephrine Bitartrate 0.9% Sodium Chloride Injection recalled Fresenius Kabi Compounding Manufacturing (CGMP) Deviations Nationwide
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.