CLASS II Drug recall · Reported 29 Mar 2023 · FDA Enforcement Report
Jardiance (Empagliflozin) recalled by Boehringer Ingelheim
Boehringer Ingelheim Pharmaceuticals is recalling Jardiance (Empagliflozin), distributed nationwide in the US. The recall was initiated on 9 Mar 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0468-2023
- FDA event ID
- 91879
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Ridgefield, CT
- Brand
- Jardiance
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Mar 2023
- FDA classified
- 17 Mar 2023
- Reported
- 29 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Diabetes Medication
Timeline
| 9 Mar 2023 | Recall initiated by company | |
| 17 Mar 2023 | Classified by FDA | +8 days |
| 29 Mar 2023 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Mix-up
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Product was distributed nationwide within the United States and PR
Questions about this recall
Why was it recalled?
Labeling: Label Mix-up
Which lots are affected?
Lot #: a) and b) E61835, exp. date JUN 2025
Where was it sold?
Product was distributed nationwide within the United States and PR
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Boehringer Ingelheim Pharmaceuticals
All 13Other Empagliflozin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Jardiance (empagliflozin tablets), 25 mg (3 blister cards with each) recalledJardiance | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Synjardy XR (empagliflozin and metformin hydrochloride recalledSynjardy | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg recalledGlyxambi | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Synjardy XR (empagliflozin and metformin) hydrochloride recalledSynjardy | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |
| Drug | CLASS II | Synjardy (empagliflozin and metformin hydrochloride) Tablets recalledSynjardy | Boehringer Ingelheim Pharmaceuticals | Other | Nationwide |