Cardinal Health Recalls Belsomra Tablets Due to Temperature Excursions
Cardinal Health is recalling 119 cartons of Belsomra (suvorexant) 10 mg tablets due to intermittent 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 and involves 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 119 cartons of Belsomra (suvorexant) 10 mg tablets. The product is identified by the code 1791139 and was distributed in Florida, Georgia, and South Carolina.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. The source text does not report any illnesses or injuries associated with this recall.
Consumers who have this product should contact their healthcare provider or pharmacist for guidance on whether to discontinue use or obtain a replacement.
The recalled product
- Product
- Belsomra (suvorexant) tablets 10 mg Each tablet contains 10 mg suvorexant. This package contains 30 Tablets in 3 Blister Cards. Each Blister Card contains 10 Tablets Rx only NDC 00006-0033-30 Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc. Whitehouse Station, NJ 08
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 119
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)
- 1791139
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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