Why it was recalled
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.
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)
Lot numbers, UPCs & expiration codes
Lots 2090019 and 2123744, Exp. 4/30/2027
Where it was sold
Nationwide in the USA and PR.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0584-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jul 21, 2025
- FDA report date
- Aug 20, 2025
- Quantity
- 51,320 cartons
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Merck & Co. Inc
Original FDA data
Every field from FDA enforcement report D-0584-2025, exactly as published.
Show all FDA fields
- City
- Rahway
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 97254
- Address
- 126 E Lincoln Ave
- Code information
- Lots 2090019 and 2123744, Exp. 4/30/2027
- Postal code
- 07065-4607
- Report date
- Aug 20, 2025
- Product type
- Drugs
- Recall number
- D-0584-2025
- Classification
- Class II
- Recalling firm
- Merck & Co. Inc
- Product quantity
- 51,320 cartons
- Reason for recall
- 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.
- Voluntary / mandated
- Voluntary: Firm initiated
- 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)
- Distribution pattern
- Nationwide in the USA and PR.
- Recall initiation date
- Jul 21, 2025
- Center classification date
- Aug 13, 2025