# FDA recall D-0584-2025

> **Merck & Co. Inc** · Class II · drug recall initiated 2025-07-21.

## Product

Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme LLC, Rahway, NJ 07065, USA, NDC 0006-0033-10 (Shellpack and Print Mat Labels), 0006-0033-30 (Carton Label)

## Reason for recall

Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which may result in delayed release of the drug, delaying onset of sleep.

## Distribution

Nationwide in the USA and PR.

## Key facts

- **Recall number:** D-0584-2025
- **Recalling firm:** Merck & Co. Inc
- **Classification:** Class II
- **Product type:** drug
- **Status:** Ongoing
- **Initiation date:** 2025-07-21
- **Report date:** 2025-08-20

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0584-2025

## Citation

> AI Analytics. FDA recall D-0584-2025. Retrieved 2026-07-08 from https://api.ai-analytics.org/recall/D-0584-2025. Source: US FDA. Licensed CC0.

---

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