HIGH

51,320 Belsomra Tablets Recalled for Delayed Dissolution Risk — Check Your Lot Numbers

Merck Sharp & Dohme LLC recalled 51,320 cartons of Belsomra (suvorexant) tablets after identifying a risk of delayed dissolution. This defect can delay the release of the drug, hindering sleep onset. Consumers and healthcare providers should stop using the product immediately and contact the company for guidance.

Quick Facts at a Glance

Recall Date
July 21, 2025
Hazard Level
HIGH
Brands
Belsomra, Merck Sharp & Dohme LLC
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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.

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Merck & Co. Inc or your healthcare provider for guidance. Notification method: N/A

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About This Product

Belsomra (suvorexant) is a prescription drug used to treat insomnia by helping patients fall asleep faster and stay asleep longer. Consumers buy it primarily for its efficacy in managing sleep disorders.

Why This Is Dangerous

The recall is due to failed dissolution specifications that may cause the drug to not release into the bloodstream effectively, delaying its intended sleep-inducing effects.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face disruptions in their sleep patterns and could experience increased anxiety or frustration related to sleeplessness due to the potential ineffectiveness of the recalled tablets.

Practical Guidance

How to identify if yours is affected

  1. Check the lot number on the packaging to determine if it is 2090019 or 2123744.
  2. Ensure the expiration date is not past 4/30/2027.
  3. Verify with your pharmacy or healthcare provider if you have any doubts about the product.

Where to find product info

The lot number and expiration date can usually be found on the bottom or back of the carton or blister pack.

What timeline to expect

Expect a refund processing time of 4-6 weeks after returning the recalled product.

If the manufacturer is unresponsive

  • Follow up with Merck & Co. through their website or phone line if you do not receive a timely response.
  • Contact the FDA to report unresponsiveness or if you require further assistance.

How to prevent similar issues

  • When purchasing medications, always check for recalls and product information.
  • Discuss sleep medication options with your healthcare provider to understand risks and benefits.
  • Stay informed on updates from pharmaceutical companies regarding product performance.

Documentation advice

Keep records of your purchase, receipts, and any communication with Merck or your healthcare provider involving the recall.

Product Details

Brand: Belsomra Model Numbers: Lots 2090019 and 2123744 Quantity: 51,320 cartons Where Sold: Nationwide in the USA and Puerto Rico NDC: 0006-0033-10 (Shellpack), 0006-0033-30 (Carton Label)

Reported Incidents

No injuries or incidents have been reported.

Key Facts

  • 51,320 cartons recalled
  • Contains 10mg suvorexant tablets
  • Delayed dissolution may affect sleep onset
  • Check lot numbers: 2090019 and 2123744
  • Stop use and contact healthcare provider for guidance.

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
7/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Details

Model Numbers
Lots 2090019 and 2123744
UPC Codes
0006-0005
0006-0033
0006-0325
+11 more
Affected States
ALL
Report Date
August 20, 2025
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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