CLASS II ONGOING Drug recall · Reported 20 Aug 2025 · FDA Enforcement Report
Belsomra (suvorexant) tablets, 10mg in 3 Blister Cards recalled
Merck & Co is recalling Belsomra (suvorexant) tablets, 10mg in 3 Blister Cards per, Each Blister Card contains, distributed nationwide in the US. The recall was initiated on 21 Jul 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0584-2025
- FDA event ID
- 97254
- Recalling firm
- Merck & Co, Rahway, NJ
- Brand
- Belsomra
- Manufacturer
- Merck Sharp & Dohme LLC
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 21 Jul 2025
- FDA classified
- 13 Aug 2025
- Reported
- 20 Aug 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- N/A
- Reason category
- Potency & Assay
Timeline
| 21 Jul 2025 | Recall initiated by company | |
| 13 Aug 2025 | Classified by FDA | +23 days |
| 20 Aug 2025 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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)
Where it was distributed
Nationwide in the USA and PR.
Questions about this recall
Is Belsomra (suvorexant) tablets, 10mg in 3 Blister Cards per, Each Blister Card contains recalled?
Yes. Merck & Co recalled Belsomra (suvorexant) tablets, 10mg in 3 Blister Cards per, Each Blister Card contains on 21 Jul 2025. The recall is Class II and its status is Ongoing. Recall number D-0584-2025.
Why was it 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.
Which lots are affected?
Lots 2090019 and 2123744, Exp. 4/30/2027
Where was it sold?
Nationwide in the USA and PR.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Merck & Co
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|---|---|---|---|---|---|
| Drug | CLASS III | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/80 mg recalled | Merck & Co | Other | Nationwide |
| Drug | CLASS III | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/10 mg recalled | Merck & Co | Packaging Defects | Nationwide |
| Drug | CLASS III | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/20 mg recalled | Merck & Co | Packaging Defects | Nationwide |
| Drug | CLASS III | Liptruzet (ezetimibe and atorvastin) tablets,10 mg/40 mg recalled | Merck & Co | Packaging Defects | Nationwide |
Other Suvorexant recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Belsomra (suvorexant) tablets contains 20 mg suvorexant recalledBelsomra | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |