FDA Drug recall D-0584-2025
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp…
- FDA Drug
- Class II
- ongoing
- Published 2025-08-20
On 2025-08-20 the FDA classified a Class II recall of Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp… by Merck And, citing 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.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0584-2025 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2025-07-21 |
| Published | 2025-08-20 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Merck And |
| Distribution | US |
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
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.
Identifiers
| ndc | 0006-0005-10 |
|---|---|
| ndc | 0006-0005-30 |
| ndc | 0006-0005-13 |
| ndc | 0006-0033-10 |
| ndc | 0006-0033-30 |
| ndc | 0006-0033-13 |
| ndc | 0006-0325-10 |
| ndc | 0006-0325-30 |
| ndc | 0006-0325-13 |
| ndc | 0006-0335-10 |
| ndc | 0006-0335-30 |
| ndc | 0006-0335-13 |
| code_info | Lots 2090019 and 2123744, Exp. 4/30/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0584-2025%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.