Merck recalls Belsomra 10mg tablets due to potential delayed drug release, risking sleep onset delays. Affected lots: 2090019 and 2123744, expiring 4/30/2027. No remedy specified.
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.
Merck is recalling Belsomra 10mg tablets that may not dissolve properly after taking, leading to delayed sleep onset. This could cause people to stay awake longer than intended, especially if they rely on the medication for sleep.
The tablets may not dissolve correctly in the stomach after taking, causing the drug to release slowly. This could delay when the medication starts working, making it harder to fall asleep as intended.
People with prescriptions for Belsomra 10mg tablets who received the recalled lots (2090019 and 2123744) from 2023 to 2027. Those with sleep issues needing this medication are most at risk.
Check your Belsomra tablets for the lot numbers 2090019 or 2123744 on the carton label. The product expires by April 30, 2027, and is sold in 30-tablet packages with 10 tablets per blister card.
Look for lot numbers 2090019 or 2123744 on the carton label to confirm if your product is affected.
The recall is for potential delayed drug release, which may cause sleep onset delays but does not pose a serious injury risk. The hazard is low risk.
Check the carton label for lot numbers 2090019 or 2123744. The product expires by April 30, 2027, and is sold in 30-tablet packages with 10 tablets per blister card.
The recall record does not specify a remedy, so no action is required beyond checking if your product is affected.
We’ve drafted a message you can send Merck to request your refund or repair — edit it as you like.
Subject: Recall D-0584-2025 — Merck Merck Hello, I own a Merck that is covered by recall D-0584-2025 from Merck. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.