Home / Recalls / Merck & Co. Inc / D-0584-2025

D-0584-2025 Class II Ongoing

Recalled by Merck & Co. Inc — Rahway, NJ

Recall Details

Product Type
Drugs
Report Date
August 20, 2025
Initiation Date
July 21, 2025
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
51,320 cartons

Product Description

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.

Distribution Pattern

Nationwide in the USA and PR.

Code Information

Lots 2090019 and 2123744, Exp. 4/30/2027

Other recalls by Merck & Co. Inc

  • D-1310-2014 Class III — Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg, a) 30 count blister (January 13, 2014)
  • D-1309-2014 Class III — Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg, a) 30 count blister (January 13, 2014)
  • D-1312-2014 Class III — Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg, a) 30 count blister (January 13, 2014)
  • D-1311-2014 Class III — Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg, a) 30 count blister (January 13, 2014)