# FDA recall D-0839-2020

> **Akorn Inc** · Class II · drug recall initiated 2019-12-16.

## Product

Hydrocortisone and Acetic Acid Otic Solution, USP, 10 mL dropper bottle, Rx only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701; NDC 50383-901-10.

## Reason for recall

Subpotent Drug: Low Out of specification (OOS) assay results for the hydrocortisone portion of this product.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0839-2020
- **Recalling firm:** Akorn Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-12-16
- **Report date:** 2020-02-19
- **Termination date:** 2022-07-29

- **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-0839-2020

## Citation

> AI Analytics. FDA recall D-0839-2020. Retrieved 2026-06-01 from https://api.ai-analytics.org/recall/D-0839-2020. Source: US FDA. Licensed CC0.

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