# FDA recall D-1080-2019

> **Akorn, Inc.** · Class III · drug recall initiated 2019-03-28.

## Product

Nystatin Oral Suspension, USP, 100,000 units per mL, 473 mL per bottle, Rx only, HI-TECH Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-587-16

## Reason for recall

Failed Impurities/Degradation Specifications: Out of Specification for an unknown impurity was observed during the 18 month stability testing.

## Distribution

AR and MS

## Key facts

- **Recall number:** D-1080-2019
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-03-28
- **Report date:** 2019-04-10
- **Termination date:** 2020-04-22

- **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-1080-2019

## Citation

> AI Analytics. FDA recall D-1080-2019. Retrieved 2026-07-10 from https://api.ai-analytics.org/recall/D-1080-2019. Source: US FDA. Licensed CC0.

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