July 2025 FDA Recall Belsomra by Merck & Co. Inc
D-0584-2025 - Failed Dissolution Specifications
This Class II drug recall was voluntarily initiated by Merck & Co. Inc on July 21, 2025 for the product Belsomra. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: 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.
07-21-2025
08-20-2025
51,320 cartons
Recall Profile & Regulatory Data
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Merck & Co. Inc
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
N/A
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA and PR.
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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)
Batch or Lot Expiration Information
Lot# Lots 2090019 and 2123744, Exp. 4/30/2027
