FDAClass IIAugust 20, 2025

Belsomra recall: Failed Dissolution

Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme…

Why was Belsomra 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.

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lots 2090019 and 2123744, Exp. 4/30/2027

Product
Belsomra (suvorexant) tablets, 10mg, 30 Tablets in 3 Blister Cards per Carton, Each Blister Card contains 10 Tablets, Rx only, Merck Sharp & Dohme…
Recalling firm
Merck & Co. Inc
Quantity
51,320 cartons
Distribution
Nationwide in the USA and PR.
Recall date
August 20, 2025
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
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