Belsomra (suvorexant) tablets recall
FDA recall D-0584-2025 · initiated Jul 21, 2025
Merck & Co. Inc recalled Belsomra (suvorexant) tablets in Jul 2025 — an FDA Class II recall (D-0584-2025) because 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.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
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.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 51,320 cartons
Details
- 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)
- Recalling company
- Merck
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA and PR.
- Initiated
- Jul 21, 2025
- FDA report date
- Aug 20, 2025
This recall is linked to a product we cover: Belsomra →
Frequently asked
- Was Belsomra (suvorexant) tablets recalled?
- Merck & Co. Inc recalled Belsomra (suvorexant) tablets in Jul 2025 — an FDA Class II recall (D-0584-2025) because 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. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Belsomra (suvorexant) tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0584-2025 was: 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.
- Is a recalled Belsomra (suvorexant) tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Belsomra (suvorexant) tablets are affected?
- Distributed: Nationwide in the USA and PR.. The recall covers these lots — Lots 2090019 and 2123744, Exp. 4/30/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0584-2025.