FDA recall D-0584-2025

Merck & Co. Inc · Class II · drug

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

Status
Ongoing
Initiation date
2025-07-21
Report date
2025-08-20
Voluntary/Mandated
Voluntary: Firm initiated
Location
Rahway, NJ, United States

Primary source

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