# FDA recall D-0818-2016

> **Fresenius Kabi USA, LLC** · Class III · drug recall initiated 2016-04-07.

## Product

Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.

## Reason for recall

Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.

## Distribution

Nationwide and Puerto Rico

## Key facts

- **Recall number:** D-0818-2016
- **Recalling firm:** Fresenius Kabi USA, LLC
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-04-07
- **Report date:** 2016-04-20
- **Termination date:** 2016-11-07

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Zurich, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0818-2016

## Citation

> AI Analytics. FDA recall D-0818-2016. Retrieved 2026-05-24 from https://api.ai-analytics.org/recall/D-0818-2016. Source: US FDA. Licensed CC0.

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