MedicineWatch US

Fresenius Kabi USA LLC Provisional

Melrose Park, IL · united states

21 recall flag(s), 2 Class I

FDA Flags (21)

Class III RecallJun 2026
Fresenius Kabi USA, LLC
Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-696
Classification: Class III
Class II RecallApr 2026
Fresenius Kabi USA, LLC
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, Frese
Classification: Class II
Class II RecallApr 2026
Fresenius Kabi USA, LLC
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,
Classification: Class II
Class II RecallApr 2026
Fresenius Kabi USA, LLC
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, M
Classification: Class II
Class II RecallApr 2026
Fresenius Kabi USA, LLC
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, Fr
Classification: Class II
Class II RecallApr 2026
Fresenius Kabi USA, LLC
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, Frese
Classification: Class II
Class II RecallApr 2026
Fresenius Kabi USA, LLC
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD B
Classification: Class II
Class II RecallApr 2026
Fresenius Kabi USA, LLC
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 ("Fres
Classification: Class II
Class II RecallApr 2026
Fresenius Kabi USA, LLC
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 ("F
Classification: Class II
Class II RecallApr 2026
Fresenius Kabi USA, LLC
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 ("Fres
Classification: Class II
Class II RecallApr 2026
Fresenius Kabi USA, LLC
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10
Classification: Class II
Class II RecallApr 2026
Fresenius Kabi USA, LLC
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 ("Fres
Classification: Class II
Class II RecallApr 2026
Fresenius Kabi USA, LLC
0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 U
Classification: Class II
Class II RecallApr 2026
Fresenius Kabi USA, LLC
0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD B
Classification: Class II
Class II RecallApr 2026
Fresenius Kabi USA, LLC
0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD
Classification: Class II
Class I RecallDec 2025
Fresenius Kabi USA, LLC
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
Classification: Class I
Class II RecallJan 2023
Fresenius Kabi USA, LLC
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.5%, 250 mg pe
Classification: Class II
Class II RecallJan 2023
Fresenius Kabi USA, LLC
Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 25 m
Classification: Class II
Class II RecallJan 2023
Fresenius Kabi USA, LLC
Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine 1:200,000 (as bitartrate), 0.25%, 125 mg p
Classification: Class II
Class I RecallMar 2022
Fresenius Kabi USA, LLC
Sodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032
Classification: Class I
Class II RecallOct 2021
Fresenius Kabi USA LLC
Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC
Classification: Class II