# FDA recall D-0297-2022

> **Teligent Pharma, Inc.** · Class II · drug recall initiated 2021-08-23.

## Product

Betamethasone Dipropionate Lotion USP, 0.05% (Augmented), 30 mL bottle, (29 g), Rx Only,  Teligent Pharma Inc., Buena, NJ, 08310, NDC 52565-023-29

## Reason for recall

Failed Stability Specifications: lot did not meet specification for the Active Pharmaceutical Ingredient (API) particle test, which was determined through routine stability testing

## Distribution

Distributed Nationwide in the USA

## Key facts

- **Recall number:** D-0297-2022
- **Recalling firm:** Teligent Pharma, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-08-23
- **Report date:** 2022-01-05
- **Termination date:** 2024-08-16

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Buena, NJ, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0297-2022

## Citation

> AI Analytics. FDA recall D-0297-2022. Retrieved 2026-06-26 from https://api.ai-analytics.org/recall/D-0297-2022. Source: US FDA. Licensed CC0.

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