Cardinal Health Recalls Pantoprazole Sodium Tablets Due to Temperature Excursions
Cardinal Health is recalling Pantoprazole Sodium Delayed-Release Tablets due to intermittent temperature excursions during storage.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
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, which typically indicates a situation where use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences. The hazard is a CGMP deviation (temperature excursion) without reported injuries or illnesses, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling Pantoprazole Sodium Delayed-Release Tablets, USP 20 mg. The recall involves 4 bottles of the medication, identified by NDC 62175-180-46 and code 20249489A. The product is distributed by Kremers Urban Pharmaceuticals Inc.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically intermittent exposure to temperature excursions during storage. This issue may affect the stability or quality of the medication.
The affected product was distributed in Florida, Georgia, and South Carolina. Consumers and healthcare providers should check their inventory for this specific product and code. If found, the product should be returned to the pharmacy or point of purchase for a refund or replacement.
The recalled product
- Product
- PANTOPRAZOLE SODIUM (PANTOPRAZOLE SODIUM)
- Brand
- PANTOPRAZOLE SODIUM
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 4
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)
- 20249489A
UPCs (2)
- 0362175617460
- 0362175180469
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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