Class II · Moderate risk
Belsomra (suvorexant)
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.
Is Suvorexant recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Suvorexant (3 total). Check the affected lots below.
Most common reason: Temperature excursion (2 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Suvorexant. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Suvorexant recalls on record
none so far in 2026; 3 on record, newest first
Class II · Moderate risk
Belsomra (suvorexant)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Belsomra (suvorexant)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
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