Belsomra Tablet, Film Coated
FDA Recall NDC 0006-0033
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 2 recorded enforcement report(s) associated with Belsomra (NDC 0006-0033). A significant event, classified as Class II, was initiated on Jul 21, 2025 by Merck Sharp & Dohme Llc. The reported reason for this action was: "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."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
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.
Jul 21, 2025
Aug 20, 2025
51,320 cartons
Recall Profile & Regulatory Data
Event ID
97254
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Merck & Co. Inc
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and PR.
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)
Batch or Lot Expiration Information
Lot# Lots 2090019 and 2123744, Exp. 4/30/2027
Affected Packages Involved in this Recall
0006-0005-10Product
0006-0005-30Product
0006-0005-13Product
0006-0033-10Product
0006-0033-30Product
0006-0033-13Product
0006-0325-10Product
0006-0325-30Product
0006-0325-13Product
0006-0335-10Product
0006-0335-30Product
0006-0335-13Product
Class II Terminated
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Mar 15, 2021
Jun 02, 2021
299 cartons
Recall Profile & Regulatory Data
Event ID
87512
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Cardinal Health Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
FL, GA, SC
Termination Date
Jun 17, 2024
Product Description
Belsomra (suvorexant) tablets 20 mg Each tablet contains 20 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets. Rx only NDC 0006-0335-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08880, USA
Batch or Lot Expiration Information
Lot# 1778598
Affected Packages Involved in this Recall
0006-0005-10Product
0006-0005-30Product
0006-0005-13Product
0006-0033-10Product
0006-0033-30Product
0006-0033-13Product
0006-0325-10Product
0006-0325-30Product
0006-0325-13Product
0006-0335-10Product
0006-0335-30Product
0006-0335-13Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
