Cardinal Health Recalls Belsomra Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 299 cartons of Belsomra (suvorexant) 20 mg tablets because of intermittent exposure to temperature excursions during storage.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class II due to a CGMP deviation (temperature excursion) without reported illnesses or injuries, fitting the criteria for a moderate severity voluntary precautionary recall.
Plain-English summary
Cardinal Health Inc. is recalling 299 cartons of Belsomra (suvorexant) 20 mg tablets. The product is a prescription medication manufactured by Merck Sharp & Dohme Corp. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage.
The affected product is identified by lot number 1778598. The distribution pattern for this recall includes Florida, Georgia, and South Carolina. Each carton contains 30 tablets in 3 blister cards.
Consumers who have this product should contact their healthcare provider for guidance. The recall is classified as FDA Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- BELSOMRA (SUVOREXANT)
- Brand
- BELSOMRA
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 299
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- 1778598
Distribution
Part of a larger recall action
This product is one of 198 recalled by Cardinal Health Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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