Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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National Drug Code

Is NDC 0597-0295-88 recalled?

Synjardy XR · 30 TABLET, EXTENDED RELEASE in 1 BOTTLE (0597-0295-88)

Yes — this exact package was recalled

1 FDA recall names the code 0597-0295-88 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
empagliflozin, metformin hydrochloride
Strength
EMPAGLIFLOZIN 25 mg/1; METFORMIN HYDROCHLORIDE 1000 mg/1
Form
Tablet, Extended Release · Oral
Labeler
Boehringer Ingelheim Pharmaceuticals, Inc.
Type
Human Prescription Drug
Product code
0597-0295

Recalls naming this package

Class II ยท Moderate risk

Synjardy XR

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Terminated Temperature excursion Cardinal Health Inc. NDC 0597-0295-88 D-0458-2021

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler