Merck Sharp & Dohme LLC recalled 51,320 cartons of Belsomra (suvorexant) tablets on July 21, 2025. The recall stems from a failure in dissolution specifications that could delay drug release. Consumers should stop using the product immediately and consult healthcare providers for guidance.
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.
Consumers and healthcare providers should stop using this product immediately. Contact Merck & Co. Inc or your healthcare provider for guidance. Notification method: N/A
The recall involves Belsomra (suvorexant) tablets, 10mg, packaged in 30 tablets per carton with 3 blister cards. The affected lot numbers are 2090019 and 2123744, with an expiration date of April 30, 2027.
The product may exhibit delayed dissolution after administration, potentially delaying the onset of sleep. This issue falls under Class II recall due to associated risks.
No specific incidents of injury or adverse events linked to this recall have been reported yet. Monitoring for any such reports will continue.
Consumers and healthcare providers should stop using Belsomra immediately. For further guidance, contact Merck & Co. Inc.
For more information, visit the FDA's recall page at https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0584-2025.
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