FDA Drugs recall ·
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per… recall
Read the official FDA notice ↗
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)
Why was it 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.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lots 2090019 and 2123744, Exp. 4/30/2027
Distribution
Nationwide in the USA and PR.
States: Puerto Rico
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0584-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.