Recalls / Class II
Class IID-0584-2025
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 name
- Belsomra
- Generic name
- Suvorexant
- Active ingredient
- Suvorexant
- Route
- Oral
- NDCs
- 0006-0005, 0006-0033, 0006-0325, 0006-0335
- FDA application
- NDA204569
- Affected lot / code info
- Lots 2090019 and 2123744, Exp. 4/30/2027
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.
Recalling firm
- Firm
- Merck & Co. Inc
- Manufacturer
- Merck Sharp & Dohme LLC
- Notification channel
- N/A
- Type
- Voluntary: Firm initiated
- Address
- 126 E Lincoln Ave, N/A, Rahway, New Jersey 07065-4607
Distribution
- Quantity
- 51,320 cartons
- Distribution pattern
- Nationwide in the USA and PR.
Timeline
- Recall initiated
- 2025-07-21
- FDA classified
- 2025-08-13
- Posted by FDA
- 2025-08-20
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0584-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.