Fresenius Kabi Compounding, LLC

Complete recall history across all FDA and CPSC categories — 15 total recalls

Fresenius Kabi Compounding, LLC appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (15)

FDA drug safety enforcement actions by Fresenius Kabi Compounding, LLC

Date Product Reason Class
Feb 5, 2026 acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injecti... Lack of Assurance of Sterility Class II
Feb 5, 2026 vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Inject... Lack of Assurance of Sterility Class II
Feb 5, 2026 vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride In... Lack of Assurance of Sterility Class II
Feb 5, 2026 ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride... Lack of Assurance of Sterility Class II
Feb 5, 2026 thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection,... Lack of Assurance of Sterility Class II
Sep 25, 2024 Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Singl... cGMP violations Class II
Sep 25, 2024 Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Singl... CGMP violations Class II
Sep 25, 2024 Vancomycin HCl 750 mg per 250 mL 0.9% Sodium Chloride Injection USP, Single D... cGMP violations Class II
Sep 25, 2024 Thiamine HCl 0.9% Sodium Chloride Injection USP, 500 mg per 100 mL, Single Do... cGMP violations Class II
Sep 25, 2024 Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 20 mg per 250 mL, Singl... cGMP violations Class II
Sep 25, 2024 NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 4 mg per 250 mL... cGMP violations Class II
Sep 25, 2024 Oxytocin 0.9% Sodium Chloride Injection USP, 30 units per 500 mL Single Dose ... cGMP violations Class II
Sep 25, 2024 EPINEPHrine 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL Single Dose B... cGMP violations Class II
Sep 25, 2024 Phenylephrine HCl 0.9% Sodium Chloride Injection USP, 10 mg per 250 mL, Singl... cGMP violations Class II
Sep 25, 2024 NORepinephrine Bitartrate 0.9% Sodium Chloride Injection USP, 8 mg per 250 mL... cGMP violations Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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