Recall Database
Fresenius Kabi Usa Recalls
An assortment of pharmaceutical pills (representative file photo). Specific recalled product: see recall details below. Photo: Michael Nutt / Wikimedia Commons (CC BY-SA 2.0).
- Recalls in database
- 15
- Agency
- FDA
- Years covered
- 2025–2026
Fresenius Kabi USA has 15 records, all FDA recalls, and 14 of them classify as drug or medication defects. The notices run from 2025 through 2026.
This is an FDA-only hub covering injectable and infusion products. Each row links to the FDA enforcement record with the recall classification and the firm's corrective action.
How this hub is built. This page collects the 15 recall records tied to Fresenius Kabi Usa in the current 411 Press recall dataset. Records are grouped by a normalized version of the recalling firm's name (normalizer version 2026-07-28.C3.2). Parent, subsidiary, and "doing business as" relationships are not merged unless the agency data states them, so a corporate family can appear under more than one name. Regulator for these records: FDA. They were published 2025–2026. A recall count reflects how much recall activity fell inside the ingestion window — roughly February 2023 through May 2026, refreshed late May 2026 — not a ranking of relative safety. Larger manufacturers and higher-volume product lines file more notices. This is the current dataset, not an all-time total, and it grows as new notices are ingested. Every row links to the original agency notice.
2026 (14)
- Class II
5% Dextrose Injection
Lack of Assurance of Sterility
- Class II
5% Dextrose Injection
Lack of Assurance of Sterility
- Class II
5% Dextrose Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.9% Sodium Chloride Injection
Lack of Assurance of Sterility
- Class II
0.45% Sodium Chloride Injection
Lack of Assurance of Sterility
2025 (1)
- Class I
Famotidine Injection
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.