Cardinal Health Recalls Meloxicam Tablets Due to Temperature Excursions
Cardinal Health Inc. is recalling 576 bottles of Meloxicam 7.5 mg tablets due to intermittent exposure to 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 involves a situation that might cause temporary or medically reversible adverse health consequences. The hazard is a storage deviation (temperature excursion) without reported illnesses or injuries, fitting the Moderate criteria for low-risk contamination or voluntary precautionary recalls.
Plain-English summary
Cardinal Health Inc. is recalling 576 bottles of Meloxicam Tablets, USP 7.5 mg (NDC 69097-158-07). The product was manufactured for Cipla USA, Inc. and 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. This condition may affect the stability and quality of the medication.
Consumers and healthcare providers should discontinue use of the affected product and contact their pharmacist or physician for guidance. The specific lot code associated with this recall is KA03034.
The recalled product
- Product
- MELOXICAM (MELOXICAM)
- Brand
- MELOXICAM
- Manufacturer
- Cardinal Health Inc.
- Category
- Drug — Prescription Drug
- Affected units
- 576
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)
- KA03034
UPCs (2)
- 0369097159078
- 0369097158071
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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