Cardinal Health Recalls Prilosec Due to Temperature Excursions
Cardinal Health is recalling Prilosec (Omeprazole Magnesium) oral suspension packets 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 the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving potential quality issues without confirmed harm.
Plain-English summary
Cardinal Health Inc. is recalling Prilosec (Omeprazole Magnesium) For Delayed-Release Oral Suspension 10 mg, 13-packet boxes. The recall is being conducted due to Current Good Manufacturing Practice (CGMP) deviations involving intermittent exposure to temperature excursions during storage.
The affected product is identified by NDC 70515-610-01 and code CACU. The product was manufactured for Covis Pharma, Zug, Switzerland, and distributed in Florida, Georgia, and South Carolina.
Consumers who have this product should stop using it and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- PRILOSEC (OMEPRAZOLE MAGNESIUM)
- Brand
- PRILOSEC
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 13
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)
- CACU
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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