# FDA recall D-0856-2021

> **Fresenius Kabi USA LLC** · Class II · drug recall initiated 2021-09-17.

## Product

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

U.S.A. Nationwide

## Key facts

- **Recall number:** D-0856-2021
- **Recalling firm:** Fresenius Kabi USA LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-09-17
- **Report date:** 2021-10-06
- **Termination date:** 2023-06-20

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Melrose Park, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0856-2021

## Citation

> AI Analytics. FDA recall D-0856-2021. Retrieved 2026-06-10 from https://api.ai-analytics.org/recall/D-0856-2021. Source: US FDA. Licensed CC0.

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