The Recall Desk
ModerateFDA (Drugs)·D-0463-2021·Announced 2021-06-02

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.

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, 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
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

Distributed in 3 states:

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.

See all 198 products in this recall →

Same brand · MELOXICAM