# FDA recall D-1391-2019

> **Teligent Pharma, Inc.** · Class III · drug recall initiated 2019-05-20.

## Product

Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC 52565-019-15) and b) 50 gram (NDC 52565-019-51) tubed, Rx Only, Manufactured by: Teligent Pharma, Inc. Buena, New Jersey 06310

## Reason for recall

Failed Impurities/Degradation Specifications

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1391-2019
- **Recalling firm:** Teligent Pharma, Inc.
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-05-20
- **Report date:** 2019-06-26
- **Termination date:** 2025-01-27

- **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-1391-2019

## Citation

> AI Analytics. FDA recall D-1391-2019. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-1391-2019. Source: US FDA. Licensed CC0.

---

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