# FDA recall D-0334-2026

> **Fresenius Kabi Compounding, LLC** · Class II · drug recall initiated 2026-02-05.

## Product

ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56

## Reason for recall

Lack of Assurance of Sterility

## Distribution

US Nationwide.

## Key facts

- **Recall number:** D-0334-2026
- **Recalling firm:** Fresenius Kabi Compounding, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2026-02-05
- **Report date:** 2026-02-18

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Canton, MA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0334-2026

## Citation

> AI Analytics. FDA recall D-0334-2026. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0334-2026. Source: US FDA. Licensed CC0.

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