Fresenius' product recalls
16 official recall notices between Dec 2025 and Aug 2026 were matched to Fresenius and brands it owned at the time, including Fresenius Kabi.
Each notice concerns the specific products, sizes and lot codes it names. A recall does not mean that other Fresenius products are affected, and a count of notices is not a measure of safety: one incident can produce a notice for every pack size.
Covers only notices from the U.S. Food and Drug Administration enforcement reports (openFDA), USDA Food Safety and Inspection Service recalls, UK Food Standards Agency food alerts and U.S. Consumer Product Safety Commission recalls that could be matched to Fresenius: the recalling firm must be Fresenius, a parent or a subsidiary, and for a brand the brand name must appear in the product description. Method.
2026 (15)
| Date | Product | Brand | Recalling firm | Reason given | Source |
|---|---|---|---|---|---|
| Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake… | Fresenius Kabi | Fresenius Kabi USA, LLC | Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL. Class I | FDA | |
| Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in a 6.5 mL vial, Rx only, Multiple Dose Vials, Fresenius Kabi, Lake Zurich, IL… | Fresenius Kabi | Fresenius Kabi USA, LLC | Presence of Particulate Matter: Hair was found in product Class II | FDA | |
| Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials, 5 mL per vial, Rx only, Sterile, Fresenius Kabi, Lake Zurich, IL 60047… | Fresenius Kabi | Fresenius Kabi USA, LLC | Presence of Particulate Matter: Hair was found in products Class II | FDA | |
| Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg per mL), Twenty-five, 20 mL Single-Dose Vials, Rx only, Fresenius Kabi, Lake… | Fresenius Kabi | Fresenius Kabi USA, LLC | Presence of Particulate Matter: Hair was found in products Class II | FDA | |
| Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multiple-Dose Vials, 20 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich,… | Fresenius Kabi | Fresenius Kabi USA, LLC | Presence of Particulate Matter: Hair was found in products Class II | FDA | |
| Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multiple-Dose Vials, 50 mL, Rx only, Sterile, Fresenius Kabi, Lake Zurich,… | Fresenius Kabi | Fresenius Kabi USA, LLC | Presence of Particulate Matter: Hair was found in products Class II | FDA | |
| Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696-02 (vial), NDC 63323-696-25 (carton) | Fresenius Kabi | Fresenius Kabi USA, LLC | Failed Impurities/Degradations Specifications Class III | FDA | |
| 0.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius… | Fresenius Kabi | Fresenius Kabi USA, LLC | Lack of Assurance of Sterility Class II | FDA | |
| 0.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047,… | Fresenius Kabi | Fresenius Kabi USA, LLC | Lack of Assurance of Sterility Class II | FDA | |
| 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a 100 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius… | Fresenius Kabi | Fresenius Kabi USA, LLC | Lack of Assurance of Sterility Class II | FDA | |
| 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"),… | Fresenius Kabi | Fresenius Kabi USA, LLC | Lack of Assurance of Sterility Class II | FDA | |
| 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"),… | Fresenius Kabi | Fresenius Kabi USA, LLC | Lack of Assurance of Sterility Class II | FDA | |
| 5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC:… | Fresenius Kabi | Fresenius Kabi USA, LLC | Lack of Assurance of Sterility Class II | FDA | |
| 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC:… | Fresenius Kabi | Fresenius Kabi USA, LLC | Lack of Assurance of Sterility Class II | FDA | |
| 5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC:… | Fresenius Kabi | Fresenius Kabi USA, LLC | Lack of Assurance of Sterility Class II | FDA |
2025 (1)
| Date | Product | Brand | Recalling firm | Reason given | Source |
|---|---|---|---|---|---|
| Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of… | Fresenius Kabi | Fresenius Kabi USA, LLC | Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. Class I | FDA |
Product descriptions and reasons are shortened from the regulators' own text; the linked notice is the authoritative record. See all matched recalls, or report a wrong match through the corrections page.