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JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-cou...

FDA Recall #D-0468-2023 — Class II — March 9, 2023

Recall #D-0468-2023 Date: March 9, 2023 Classification: Class II Status: Terminated

Product Description

JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-0153-30) and b) 90-count (NDC 0597-0153-90) bottles, Rx only, Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Eli Lilly and Company Indianapolis, IN 46285 USA

Reason for Recall

Labeling: Label Mix-up

Recalling Firm

Boehringer Ingelheim Pharmaceuticals, Inc. — Ridgefield, CT

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

69,375 bottles

Distribution

Product was distributed nationwide within the United States and PR

Code Information

Lot #: a) and b) E61835, exp. date JUN 2025

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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