Empagliflozin recalls

The FDA has published 6 recalls involving Empagliflozin since 2018. The latest was reported on 3 Jan 2024. Most were for manufacturing (cgmp) deviations. Cardinal Health has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls6since 2018

Last 12 months0reported

Class I00% of total

Ongoing0latest 3 Jan 2024

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 6 100%Class III 0 0%

Why empagliflozin is recalled

Companies

Cardinal Health350%
Boehringer Ingelheim Pharmaceuticals233%
Cardinal Healthcare117%

Brands

By year

2024117%
2023117%
2021350%
2018117%

All empagliflozin recalls, newest first

6 total

Reported	Class	Recall	Company	Reason	Where
3 Jan 2024Drug	CLASS II	Jardiance (empagliflozin tablets), 25 mg (3 blister cards with each) recalledJardiance	Cardinal Healthcare	Manufacturing (CGMP) Deviations	Nationwide
29 Mar 2023Drug	CLASS II	Jardiance (Empagliflozin) recalled by Boehringer IngelheimJardiance	Boehringer Ingelheim Pharmaceuticals	Packaging Defects	Nationwide
2 Jun 2021Drug	CLASS II	Synjardy XR (empagliflozin and metformin hydrochloride recalledSynjardy	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
2 Jun 2021Drug	CLASS II	Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg recalledGlyxambi	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
2 Jun 2021Drug	CLASS II	Synjardy XR (empagliflozin and metformin) hydrochloride recalledSynjardy	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC
3 Oct 2018Drug	CLASS II	Synjardy (empagliflozin and metformin hydrochloride) Tablets recalledSynjardy	Boehringer Ingelheim Pharmaceuticals	Other	Nationwide

Should you stop taking Empagliflozin?

Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.