FDA Recall D-0584-2025

Merck & Co. Inc · Rahway, NJ

Class II Ongoing 297 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

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

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.

Recall record

Recall number: D-0584-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: N/A
Distribution: Nationwide in the USA and PR.
Recall initiated: 2025-07-21
Classified by FDA Center: 2025-08-13
FDA published: 2025-08-20
Recalling firm: Merck & Co. Inc
Firm location: Rahway, NJ

Drug identification

Brand name(s): BELSOMRA
Generic name(s): SUVOREXANT
Manufacturer(s): Merck Sharp & Dohme LLC
NDC(s): 0006-0005, 0006-0033, 0006-0325, 0006-0335
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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