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Recall Observatory FDA recall evidence

Drug 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)

D-0584-2025

July 21, 2025

Class II

Product summary

Firm
Merck & Co. Inc
Event
Event 97254
Status
Ongoing
Classification
Class II
Quantity
51,320 cartons
Official record key
drug-enforcement:D-0584-2025

Official wording

Reason: 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.

Code information: Lots 2090019 and 2123744, Exp. 4/30/2027

Distribution pattern: Nationwide in the USA and PR.

Derived failure modes

  • Potency or specification failure

    reason.potency_specification_failure · v1.0.0

    Failed Dissolution Specifications