Belsomra — Class II drug recall D-0584-2025
Ongoing recall by Merck & Co. Inc, reported 2025-08-20, distributed nationwide. Failed Dissolution Specifications: potential for delayed dissolution of the dose after administration which ma
| Recall number | D-0584-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Merck & Co. Inc, Rahway, NJ, United States |
| Recall initiated | 2025-07-21 |
| Classified | 2025-08-13 |
| Reported by FDA | 2025-08-20 |
| Distributed | Nationwide (US) |
| Quantity | 51,320 cartons |
| Reason classes | specification failure |
| NDC | 00006-0005, 00006-0005-10, 00006-0005-13, 00006-0005-30, 00006-0033, 00006-0033-10, 00006-0033-13, 00006-0033-30, 00006-0325, 00006-0325-10, 00006-0325-13, 00006-0325-30, 00006-0335, 00006-0335-10, 00006-0335-13, 00006-0335-30 |
| Lot numbers | 2090019, 2123744 |
| Expiration dates | 2027-04-30 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0584-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.