FDAFDA · Food and drugs·Recall number D-0584-2025
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)
Published August 20, 2025 · Recall initiated: July 21, 2025
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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 to do
Voluntary: Firm initiated
Recall details
- Brand
- BELSOMRA
- Manufacturer
- Merck & Co. Inc
- Distributor
- Nationwide in the USA and PR.
- Lot
- Lots 2090019 and 2123744, Exp. 4/30/2027
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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