FDAHealthJuly 21, 2025
Merck & Co. Inc — 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 000
⚠️ 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.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- July 21, 2025
Nationwide in the USA and PR.
What's affected?
- 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)
- Brand
- BELSOMRA
- Lot code
- 2090019
Additional details
Lots 2090019 and 2123744, Exp. 4/30/2027
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 51,320 cartons.
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