# FDA recall D-1258-2020

> **Akorn Inc** · Class III · drug recall initiated 2020-03-25.

## Product

Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 10 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-02

## Reason for recall

Failed impurities/degradation specification: Out-of-Specification result for total impurity at 4.1% (Limit: NMT 3.0%) during retained sample testing.

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-1258-2020
- **Recalling firm:** Akorn Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2020-03-25
- **Report date:** 2020-04-08
- **Termination date:** 2022-07-28

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1258-2020

## Citation

> AI Analytics. FDA recall D-1258-2020. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-1258-2020. Source: US FDA. Licensed CC0.

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