Class II
Ongoing
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)
- Company
- Merck & Co. Inc
- Recall Initiated
- July 21, 2025
- Posted
- August 20, 2025
- Recall Number
- D-0584-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 51,320 cartons
- Firm Location
- Rahway, NJ, United States
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.
Lot / Code Info
Lots 2090019 and 2123744, Exp. 4/30/2027
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