Drug recall D-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)
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.
Lots and codes
Lots 2090019 and 2123744, Exp. 4/30/2027
Recall details
- Recalling firm
- Merck & Co. Inc, Rahway, NJ
- Quantity
- 51,320 cartons
- Distribution
- Nationwide in the USA and PR.
- Type
- Voluntary: Firm initiated
- Recall initiated
- July 21, 2025
Related products
- Belsomra – drug information
- NDC 0006-0325 Belsomra · Suvorexant 15 mg/1 · Merck Sharp & Dohme LLC
- NDC 0006-0005 Belsomra · Suvorexant 5 mg/1 · Merck Sharp & Dohme LLC
- NDC 0006-0033 Belsomra · Suvorexant 10 mg/1 · Merck Sharp & Dohme LLC
- NDC 0006-0335 Belsomra · Suvorexant 20 mg/1 · Merck Sharp & Dohme LLC