# FDA recall D-0690-2022

> **Teligent Pharma, Inc.** · Class II · drug recall initiated 2022-03-15.

## Product

Hydrocortisone Butyrate Lotion 0.1%, 4 fl. oz. (118 mL) bottle, Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-159-04.

## Reason for recall

cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.

## Distribution

Nationwide in the USA and Puerto Rico

## Key facts

- **Recall number:** D-0690-2022
- **Recalling firm:** Teligent Pharma, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2022-03-15
- **Report date:** 2022-03-30
- **Termination date:** 2024-06-17

- **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-0690-2022

## Citation

> AI Analytics. FDA recall D-0690-2022. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-0690-2022. Source: US FDA. Licensed CC0.

---

*[Dataset catalog](/datasets/) · [FDA recalls dataset](/datasets/fda-recalls) · CC0 1.0*