The Recall Desk
HighFDA (Drugs)·D-0468-2023·Announced 2023-03-29

Prescription Drug Recall: Jardiance Empagliflozin 25 mg Label Mix-Up

Boehringer Ingelheim Pharmaceuticals is recalling Jardiance (Empagliflozin) 25 mg tablets due to a label mix-up affecting 69,375 bottles distributed nationwide.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The recall involves a label mix-up on a prescription medication, representing a risk-of-harm to patients where injury has not yet been reported. This meets the Score 3 threshold per the labeling error criteria.

Plain-English summary

Boehringer Ingelheim Pharmaceuticals, Inc. is recalling Jardiance (Empagliflozin) 25 mg tablets due to a label mix-up. The affected product was distributed nationwide in the United States and Puerto Rico.

The recall involves 69,375 bottles of Jardiance (Empagliflozin) 25 mg tablets packaged in 30-count and 90-count bottles. Lot E61835 with an expiration date of June 2025 is affected.

Consumers who have bottles from this recall should stop using the product and contact their healthcare provider or pharmacist for guidance. Questions about this recall may be directed to Boehringer Ingelheim Pharmaceuticals, Inc.

The recalled product

Product
JARDIANCE (EMPAGLIFLOZIN)
Brand
JARDIANCE
Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.
Category
Drug
Hazard
  • mis-labeling

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 (2)

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

Distribution

Distributed nationwide across the United States.

Related recalls

Same brand · JARDIANCE

Same category