# FDA recall D-0802-2021

> **Akorn, Inc.** · Class II · drug recall initiated 2021-08-13.

## Product

Betamethasone Dipropionate Lotion USP (Augmented), 0.05%, packaged in a) 30 mL bottle (NDC 61748-480-30), b) 60 mL bottle (NDC 61748-480-60), Rx only, Manufactured by: Hi-Tech Pharmacal Co. Inc., Amityville,NY 11701

## Reason for recall

Failed impurities/degradation specification: Out of Specification for an unknown impurity observed in topical product.

## Distribution

USA Nationwide

## Key facts

- **Recall number:** D-0802-2021
- **Recalling firm:** Akorn, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-08-13
- **Report date:** 2021-09-22
- **Termination date:** 2022-08-17

- **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-0802-2021

## Citation

> AI Analytics. FDA recall D-0802-2021. Retrieved 2026-07-19 from https://api.ai-analytics.org/recall/D-0802-2021. Source: US FDA. Licensed CC0.

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