Home / Recalls / Fresenius Kabi USA LLC / D-0856-2021

D-0856-2021 Class II Terminated

Recalled by Fresenius Kabi USA LLC — Melrose Park, IL

FDA drug recall D-0856-2021 was initiated by Fresenius Kabi USA LLC on September 17, 2021 and is designated Class II. Reason for recall: Defective container: Cracked vials leading to lack of sterility assurance The recall status is terminated (terminated June 20, 2023). Affected quantity: 963000 vials.

Recall Details

Product Type
Drugs
Report Date
October 6, 2021
Initiation Date
September 17, 2021
Termination Date
June 20, 2023
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
963000 vials

Product Description

Morphine Sulfate Injection, USP, 2 mg per mL, 1 mL single dose vial, Rx only, Fresenius Kabi, Lake Zurich, IL 60047, NDC 63323-452-01. 25 vials per tray packaged 18 trays per shipper

Reason for Recall

Defective container: Cracked vials leading to lack of sterility assurance

Distribution Pattern

U.S.A. Nationwide

Code Information

Lot # 6023731, 6023732, Exp 03/2023; 6024172, 6024260, Exp 06/2023

Other recalls by Fresenius Kabi USA LLC

  • D-0727-2026 Class II — Naropin (ropivacaine hydrochloride Injection, USP), 0.5%, 100 mg per 20 mL (5 mg (July 16, 2026)
  • D-0726-2026 Class II — Lidocaine HCl Injection, USP, 2%, 100 mg per 5 mL (20 mg per mL), 25 Single Dose (July 16, 2026)
  • D-0729-2026 Class II — Xylocaine (lidocaine HCl Injection, USP), 1%, 500 mg per 50 mL (10 mg per mL), 2 (July 16, 2026)
  • D-0728-2026 Class II — Xylocaine (lidocaine HCl Injection, USP), 1%, 200 mg per 20 mL (10 mg per mL), 2 (July 16, 2026)
  • D-0725-2026 Class II — Glycopyrrolate Injection, USP, 1 mg per 5 mL (0.2 mg per mL), 25 x 5 mL fill in (July 16, 2026)
  • D-0581-2026 Class III — Epinephrine Injection, USP, 1mg/mL, 1 mL single-dose vial, Rx only, Fresenius Ka (May 14, 2026)
  • Z-2223-2026 Class I — LVP software of the Ivenix Infusion System (IIS); Product Code LVP-SW-0005. (May 6, 2026)
  • Z-2224-2026 Class I — Ivenix Infusion System (IIS), Large Volume Pump, Model Number: LVP-0004 (May 6, 2026)
  • D-0436-2026 Class II — 5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL free (March 11, 2026)
  • D-0427-2026 Class II — 0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL (March 11, 2026)

FDA data resources