# FDA recall D-1241-2019

> **Akorn Inc** · Class III · drug recall initiated 2019-04-23.

## Product

Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per carton, (2 mL each), Rx only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045, NDC 17478-030-25

## Reason for recall

Failed impurities/degradation specification: Out of Specification result for total impurity at 4.0% (Limit:  NMT 3.0%) at 12 months stability testing.

## Distribution

U.S.A. Nationwide

## Key facts

- **Recall number:** D-1241-2019
- **Recalling firm:** Akorn Inc
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-04-23
- **Report date:** 2019-05-01
- **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-1241-2019

## Citation

> AI Analytics. FDA recall D-1241-2019. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-1241-2019. Source: US FDA. Licensed CC0.

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