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
What to Do Now
Use this page like a recall checklist: verify the product first, then act on the official remedy.
Immediate steps
- 1Stop using the product until you confirm whether it is included in the recall.
- 2Compare the product label, model number, UPC, color, size, and purchase location against the identifiers below.
- 3Follow the official remedy from FDA - Drug Safety; save photos, receipts, labels, and correspondence before contacting the company.
- 4If the product could harm a child, older adult, pet, or patient, move it out of reach immediately.
Check these identifiers
- Brand
- Belsomra, Merck Sharp & Dohme LLC
- Product type
- Tablets
- Model numbers
- Lots 2090019 and 2123744
- UPC codes
- 0006-0005, 0006-0033, 0006-0325, 0006-0335, 0006-0005-10, 0006-0005-30, 0006-0005-13, 0006-0033-10 +6 more
- Sold at
- Multiple Retailers
- Where affected
- ALL
Recall Timeline
Key dates and source checks for this recall record.
Recall announced
July 21, 2025
Reported by FDA DRUG
August 20, 2025
RecallRadar source check
April 18, 2026
Consumer action
Use the official remedy and keep documentation.
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
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
- Check the lot number on the packaging to determine if it is 2090019 or 2123744.
- Ensure the expiration date is not past 4/30/2027.
- 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.
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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
- Contains 10mg suvorexant tablets
- Delayed dissolution may affect sleep onset
- Check lot numbers: 2090019 and 2123744
- Stop use and contact healthcare provider for guidance.
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Safety Guide
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