Class II · Moderate risk
Synjardy XR Tablets
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
JARDIANCE (Empagliflozin)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Labeling: Label Mix-up
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
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
Affected NDC
0597-0153-90
Compare with the code on your package — it is the most precise check available.
Drug: Empagliflozin Category: Diabetes Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Jardiance Empagliflozin NDC 00597-0153 |
25 mg/1 | Tablet, Film Coated Oral |
Boehringer Ingelheim Pharmaceuticals, Inc. | Rx |
- Recalling firm
- Boehringer Ingelheim Pharmaceuticals, Inc.
- NDC code
- 0597-0153-30
- Origin
- CT, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0468-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Empagliflozin recalls
See all
Class II · Moderate risk
Jardiance (empagliflozin tablets)
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Synjardy XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Synjardy XR
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class II · Moderate risk
Synjardy (empagliflozin and metformin hydrochloride)
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Other recalls by Boehringer Ingelheim Pharmaceuticals, Inc.
All 2023 recalls
Class II · Moderate risk
Synjardy XR Tablets
CGMP Deviations: An incorrect detergent was used and the required swab sampling was not performed on a production hopper that had previously been used for a different product.
Class II · Moderate risk
Micardis Tablets
Subpotent Drug
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
Class II · Moderate risk
Catapres (clonidine hydrochloride, USP)
An extraneous peak was observed for dissolution testing.
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