[pending] BELSOMRA (SUVOREXANT)
Pending LLM rewrite. Source: FDA_DRUG D-0584-2025.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
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 recalled product
- Product
- BELSOMRA (SUVOREXANT)
- Brand
- BELSOMRA
- Manufacturer
- Merck & Co. Inc
- Category
- Drug — Drugs
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lots 2090019 and 2123744
- Exp. 4/30/2027
Distribution
Distributed nationwide across the United States.
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