Merck & Co. Inc: Drug Recall
Recall #D-0584-2025 · 07/21/2025
Class II: Risk
Recall Details
- Recall Number
- D-0584-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Merck & Co. Inc
- Status
- Ongoing
- Date Initiated
- 07/21/2025
- Location
- Rahway, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 51,320 cartons
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.
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)
Distribution Pattern
Nationwide in the USA and PR.
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.