# FDA recall D-0247-2015

> **Fresenius Kabi USA LLC** · Class III · drug recall initiated 2014-04-14.

## Product

HALOPERIDOL DECANOATE INJECTION, 50 mg/mL, 1 mL vial, Rx only, Fresenius Kabi USA, LLC, Schaumburg, IL 60173 NDC  63323-469-01

## Reason for recall

Failed Impurities/Degradation Specifications: Fresenius Kabi is recalling three lots of Haloperidol Decanoate Injection due to an out-of-specification result.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0247-2015
- **Recalling firm:** Fresenius Kabi USA LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-04-14
- **Report date:** 2014-11-19
- **Termination date:** 2016-03-08

- **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-0247-2015

## Citation

> AI Analytics. FDA recall D-0247-2015. Retrieved 2026-06-16 from https://api.ai-analytics.org/recall/D-0247-2015. Source: US FDA. Licensed CC0.

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