Drug Enforcement D-0584-2025

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.

Status

Ongoing

Classification

Class II

Report Date

August 20, 2025

Termination Date

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Product Information

Product description
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)
Product quantity
51,320 cartons
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.
Recall initiation reason
—
Initial firm notification
N/A
Distribution pattern
Nationwide in the USA and PR.

Location & Firm

Recalling firm
Merck & Co. Inc
Address
126 E Lincoln Ave, N/A

United States
Voluntary / Mandated
Voluntary: Firm initiated
Status date
—

Codes & Dates

Recall number
D-0584-2025
Event ID
97254
Recall initiation date
July 21, 2025
Center classification date
August 13, 2025
Code info
Lots 2090019 and 2123744, Exp. 4/30/2027
More code info
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