# FDA recall D-0619-2020

> **Glenmark Pharmaceuticals Inc., USA** · Class III · drug recall initiated 2019-11-15.

## Product

Clobetasol Propionate Foam (Emulsion Formulation), 0.05% a) 50 g pack (NDC 68462-625-27) and b) 100 g pack (NDC 68462-625-94), Rx Only, Manufactured by: Glenmark Pharmaceuticals Limited Plot No. B-25, MIDC, Shendra Aurangabad, Maharashtra -431210, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430

## Reason for recall

Defective delivery system; product is not foaming or is coming out as liquid.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0619-2020
- **Recalling firm:** Glenmark Pharmaceuticals Inc., USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2019-11-15
- **Report date:** 2019-12-18
- **Termination date:** 2024-03-15

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0619-2020

## Citation

> AI Analytics. FDA recall D-0619-2020. Retrieved 2026-06-03 from https://api.ai-analytics.org/recall/D-0619-2020. Source: US FDA. Licensed CC0.

---

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