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Belsomra recalls

Belsomra products have been recalled 2 times, most recently on 20 Aug 2025. The recalling company is usually Cardinal Health. The most common reason is potency & assay.

Total recalls2since 2021

Last 12 months0reported

Class I00% of total

Ongoing1latest 20 Aug 2025

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 1 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 100%Class III 0 0%

Why belsomra is recalled

Potency & Assay150%
Manufacturing (CGMP) Deviations150%

Companies

Cardinal Health150%
Merck & Co150%

By year

2025150%
2021150%

Ongoing belsomra recalls

1 active

Reported	Class	Recall	Company	Reason	Where
20 Aug 2025Drug	CLASS II	Belsomra (suvorexant) tablets, 10mg in 3 Blister Cards recalledBelsomra	Merck & Co	Potency & Assay	Nationwide

All belsomra recalls, newest first

2 total

Reported	Class	Recall	Company	Reason	Where
20 Aug 2025Drug	CLASS II	Belsomra (suvorexant) tablets, 10mg in 3 Blister Cards recalledBelsomra	Merck & Co	Potency & Assay	Nationwide
2 Jun 2021Drug	CLASS II	Belsomra (suvorexant) tablets contains 20 mg suvorexant recalledBelsomra	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.