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 Indianapoli

FDA recall notice · announced March 29, 2023 · Boehringer Ingelheim Pharmaceuticals

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Notes

Distribution: Product was distributed nationwide within the United States and PR
Lot/code information: Lot #: a) and b) E61835, exp. date JUN 2025
Quantity: 69,375 bottles
Status: Terminated
Products in this recall event:
- 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. Ridgefi (D-0468-2023)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.