Fresenius Kabi recalls
FDA enforcement reports naming Fresenius Kabi USA LLC as the recalling firm.
- Recall reports
- 70
- Class I (serious)
- 13
- Most recent report
- Sep 2, 2026
- Sep 2, 2026Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manu…Drug · Fresenius Kabi USA, LLCPresence of particulate matter:An internal investigation at the firm found the product to contain glass particles.Class I
- Aug 26, 2026Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes…Drug · Fresenius Kabi USA, LLCLabeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.Class I
- Jul 29, 2026Glycopyrrolate Injection, USP, 1 mg per 5 mL (0Drug · Fresenius Kabi USA, LLCPresence of Particulate Matter: Hair was found in productClass II
- Jul 29, 2026Naropin (ropivacaine hydrochloride Injection, USP), 0Drug · Fresenius Kabi USA, LLCPresence of Particulate Matter: Hair was found in productsClass II
- Jul 29, 2026Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose Vials,…Drug · Fresenius Kabi USA, LLCPresence of Particulate Matter: Hair was found in productsClass II
- Jul 29, 2026Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 25 Multi…Drug · Fresenius Kabi USA, LLCPresence of Particulate Matter: Hair was found in productsClass II
- Jul 29, 2026Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 25 Multi…Drug · Fresenius Kabi USA, LLCPresence of Particulate Matter: Hair was found in productsClass II
- Jun 17, 2026Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lak…Drug · Fresenius Kabi USA, LLCFailed Impurities/Degradations SpecificationsClass III
- Apr 15, 20260.45% Sodium Chloride Injection, USP, 1.125 grams per 250 mL (4.5 mg per mL), 250 mL in…Drug · Fresenius Kabi USA, LLCLack of Assurance of SterilityClass II
- Apr 15, 20260.9% Sodium Chloride Injection, USP 0.9% (450 mg per 50 mL) (9 mg per mL) 50 mL, Rx onl…Drug · Fresenius Kabi USA, LLCLack of Assurance of SterilityClass II
- 0.9% Sodium Chloride Injection, USP, 0.9% (900 mg per 100 mL) (9 mg per mL) 100 mL in a…
- 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 25…
- 0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 50…
- 0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton…
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single…
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single…
- 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single…
- 0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Sing…
- 0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Sing…
- 5% Dextrose Injection, USP 2
- 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex ba…
- 5% Dextrose Injection, USP 12
- Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Freseniu…
- Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200…
- Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000…
- Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000…
- Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20…
- Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius…
- Xylocaine-MPF with Epinephrine 1:200,000, (Lidocaine HCl and Epinephrine Injection, USP…
- Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials…
- Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL…
- Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP), 0
- Dexmedetomidine HCl in 0
- DOXOrubicin Hydrochloride Injection, USP, 10 mg / 5 mL (2 mg / mL), 5 mL fill in a 6 mL…
- Dexmedetomidine HCl in 0
- Fosaprepitant for Injection, 150 mg / vial in a 10 mL Single-Dose vial, Rx only, Fresen…
- Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single Dose Vials…
- Ketorolac Tromethamine Injection, USP, 60 mg per 2 mL (30 mg per mL), packaged in 2 mL…
- Fluorouracil Injection, USP, 5 g / 100 mL (50 mg / mL), 100 mL fill in a 100 mL vial, R…
- Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kabi USA, LLC…
- SODIUM CHLORIDE INJECTION, USP, 0
- SODIUM CHLORIDE INJECTION, USP, 0
- Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd
- Midazolam Injection, USP, Preservative Free, 2 mg / 2 mL (1 mg / mL), 24 X 2mL Prefille…
- Fluphenazine Decanoate Injection, USP
- MIDAZOLAM INJECTION, USP, *25 mg/5 mL, (5 mg/ mL), 5 mL vials, 10 Vials per carton, Rx…
- Sensorcaine- MPF (Bupivacaine HCI Injection, USP), 0
- OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0
- OCTREOTIDE ACETATE INJECTION, 50 mcg (base)/mL (0
- Cisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous inject…
- Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only
- Hydralazine Hydrochloride Injection, USP, 20 mg/mL, 1 mL fill, in a 2 mL
- Rifampin for Injection, USP 600mg/vial in a 20mL vial, Rx only, Manufactured for Fresen…
- KABIVEN [(3
- MIDAZOLAM HYDROCHLORIDE INJECTION, 5 mg/1 mL, C-IV, For IM or IV Use, 2 mL Vials, Rx only
- GENTAMICIN INJECTION, USP, equivalent to 40 mg/mL, Rx only, 20 mL Multiple Dose Vial, M…
- CYANOCOBALAMIN INJECTION, USP, 1000 mcg/mL, For IM or IV Use, Multiple Dose 2 mL Vials,…
- ONDANSETRON INJECTION, USP, 4 mg/ 2 mL (2 mg/mL), For IM or IV Use, Single Dose 2 mL V…
- HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC,…
- PROPRANOLOL HYDROCHLORIDE INJECTION, USP 1 mg/mL, 1 mL Single Dose Vial, Rx only, APP P…
- Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium…
- Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodiu…
- Heparin Sodium Injection, USP 10,000 USP units per 10 mL (1,000 USP units per mL) For I…
- Tranexamic Acid Injection USP, 1000mg/10mL, 10mL vial, Rx only
- FOLIC ACID INJECTION, USP
- PACLITAXEL INJECTION, USP (semisynthetic)
- Magnesium Sulfate Injection, USP, 50% (25 grams/50 mL), For IM or IV Use, 50 mL, Single…
- Oxytocin Injection, USP, (Synthetic), 10 USP Units/mL, for IV Infusion or IM Use, Rx On…
- Folic Acid Injection, USP, 5 mg/mL, For IM, IV or SC Use, 10 mL, Multiple Dose Vial, Rx…
- Benztropine Mesylate Injection, USP, 2 mg/2 mL (1 mg/1 mL), 2 mL Single Dose Vial, Rx o…
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