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 tablets)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Cause type: Temperature excursion
The product was stored or shipped outside its labeled temperature range. Heat or freezing can degrade a drug without any visible change, so it may be weaker than labeled. All temperature excursion recalls.
What was recalled
Jardiance (empagliflozin tablets), 25 mg, 30 tablets (3 blister cards with 10 tablets each), Rx only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877. NDC: 0597-0153-37
Affected NDC
0597-0153-37
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
- Cardinal Healthcare
- Origin
- OH, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0185-2024 · 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)
Labeling: Label Mix-up
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 Cardinal Healthcare
All 2022 recalls
Class II · Moderate risk
Inhub Wixela
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Warfarin Sodium Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Warfarin Sodium Tablets
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
Class II · Moderate risk
Triamterene and Hydrochlorothiazide Capsules
CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
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