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)
Reported: August 20, 2025 Initiated: July 21, 2025 #D-0584-2025
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)
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.
Details
- Recalling Firm
- Merck & Co. Inc
- Units Affected
- 51,320 cartons
- Distribution
- Nationwide in the USA and PR.
- Location
- Rahway, NJ
Frequently Asked Questions
What product was recalled? ▼
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). Recalled by Merck & Co. Inc. Units affected: 51,320 cartons.
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 20, 2025. Severity: Moderate. Recall number: D-0584-2025.
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