Belsomra 10 mg tablets failed dissolution, which may delay sleep onset
Belsomra (suvorexant) 10 mg tablets are being recalled because of failed dissolution specifications, with potential for delayed release of the drug and delayed onset of sleep. 51,320 cartons affected.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall for an out-of-specification dissolution result where the stated consequence is a delayed onset of sleep rather than a safety hazard.
Plain-English summary
Belsomra (suvorexant) tablets, 10 mg, 30 tablets in three blister cards per carton, prescription only, from Merck Sharp & Dohme LLC of Rahway, New Jersey, NDC 0006-0033-10, are being recalled. The action covers 51,320 cartons.
The stated reason is failed dissolution specifications: the potential for delayed dissolution of the dose after administration, which may result in delayed release of the drug, delaying onset of sleep. The FDA classified the action as Class II.
Affected lots are 2090019 and 2123744, expiring 4/30/2027. Distribution was nationwide in the USA and Puerto Rico.
Patients holding affected lots should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by Merck.
The recalled product
- Product
- BELSOMRA (SUVOREXANT)
- Brand
- BELSOMRA
- Manufacturer
- Merck & Co. Inc
- Category
- Drug — Oral tablet
- Affected units
- 51,320
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
Related recalls
Same brand · BELSOMRA
- ModerateCardinal Health Recalls Belsomra Tablets Due to Temperature Excursions
FDA (Drugs) · 2021-06-02
Same manufacturer · Merck & Co. Inc
See all →- LowMerck Recalls Liptruzet Tablets Due to Packaging Defects
FDA (Drugs) · 2014-05-14
- LowMerck Recalls Liptruzet Tablets Due to Packaging Defects
FDA (Drugs) · 2014-05-14
- LowMerck Recalls Liptruzet Tablets Due to Packaging Defects
FDA (Drugs) · 2014-05-14
- LowMerck Recalls Liptruzet Tablets Due to Defective Outer Packaging
FDA (Drugs) · 2014-05-14
Same hazard · dissolution failure
See all →- ModerateAscend Recalls Amlodipine and Olmesartan Medoxomil Tablets for Dissolution Issues
FDA (Drugs) · 2026-10-28
- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateAjanta Pharma Recalls Ranolazine Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateMylan Recalls Mycophenolate Mofetil Injection Due to Dissolution Failures
FDA (Drugs) · 2026-09-09
- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
Similar recalls
- LowMcKesson Recalls bupropion Hydrochloride Extended-Release Tablets for Dissolution Failures
FDA (Drugs) · 2012-10-10
- HighFDA Recalls Divalproex Sodium Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2022-08-03
- LowTeva Recalls Risedronate Sodium Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2017-01-25
- HighAscend amlodipine and olmesartan tablets failed dissolution specifications
FDA (Drugs) · 2026-06-10
- ModerateTeva Recalls Risedronate Sodium Tablets Due to Dissolution Failures
FDA (Drugs) · 2017-03-15
- ModerateDoxylamine Succinate and Pyridoxine Hydrochloride Tablets Recalled for Failed Dissolution
FDA (Drugs) · 2022-02-09