D-0584-2025 Class II Ongoing
FDA drug recall D-0584-2025 was initiated by Merck & Co. Inc on Jul 21, 2025 and is designated Class II. 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. The recall status is ongoing. Affected quantity: 51,320 cartons.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 20, 2025
- Initiation Date
- Jul 21, 2025
- 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
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0584-2025
- openFDA file date
- Nov 10, 2026
- Loaded by RegDataLab
- Nov 11, 2026