Medications & Supplements/Prescription Drugs

Belsomra (suvorexant) Tablets Recalled for Failed Dissolution Specifications

Agency Publication Date: August 13, 2025

Summary

Merck & Co. Inc. is recalling 51,320 cartons of Belsomra (suvorexant) 10mg tablets because the medication may fail to dissolve at the required rate. This quality issue can cause a delayed release of the drug, which may result in a longer time for the patient to fall asleep after taking the dose. The recall includes 30-count cartons that contain three blister cards of 10 tablets each.

Risk

If the tablets do not dissolve as specified, the onset of sleep may be delayed, rendering the treatment less effective than intended for the patient.

What You Should Do

This recall affects Belsomra (suvorexant) 10mg tablets packaged in 30-count cartons (NDC 0006-0033-10 and 0006-0033-30), which contain three blister cards of 10 tablets each.
Check your medication packaging for lot numbers 2090019 and 2123744 with an expiration date of 4/30/2027.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Belsomra (suvorexant) tablets (10mg)by Belsomra

Variants: 10mg, Tablet

Lot Numbers:

2090019 (Exp. 4/30/2027)

2123744 (Exp. 4/30/2027)

NDC:

0006-0033-10

0006-0033-30

30 Tablets in 3 Blister Cards per Carton

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 97254

Status: Active

Manufacturer: Merck & Co. Inc

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 51,320 cartons

Distributed To: Nationwide

Agency Last Updated: August 20, 2025

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

This recall affects Belsomra (suvorexant) 10mg tablets packaged in 30-count cartons (NDC 0006-0033-10 and 0006-0033-30), which contain three blister cards of 10 tablets each.

Check your medication packaging for lot numbers 2090019 and 2123744 with an expiration date of 4/30/2027.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.