The Recall Desk
ModerateFDA (Drugs)·D-0584-2025·Announced 2025-08-20

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.

What this means for you

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
Hazard
  • dissolution-failure
  • delayed-release
  • out-of-specification
  • class-ii

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.

Related recalls

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