Merck & Co. Inc recalls Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, R…

Recall date

July 21, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0584-2025

FDA classification

Class II

Brand / firm

Merck & Co. Inc

Sold / distributed

Nationwide in the USA and PR.

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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)