Semglee (insulin Glargine recalls

The FDA has published 1 recall involving Semglee (insulin Glargine since 2022. The latest was reported on 26 Jan 2022. Most were for labeling errors. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.

Total recalls1since 2022

Last 12 months0reported

Class I1100% of total

Ongoing0latest 26 Jan 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 1 100%Class II 0 0%Class III 0 0%

Why semglee (insulin glargine is recalled

Labeling Errors1100%

Companies

Mylan Pharmaceuticals1100%

By year

20221100%

All semglee (insulin glargine recalls, newest first

1 total

Reported	Class	Recall	Company	Reason	Where
26 Jan 2022Drug	CLASS I	Semglee (insulin glargine) injection/mL (U-100) Prefilled Pen recalled	Mylan Pharmaceuticals	Labeling Errors	Nationwide

Should you stop taking Semglee (insulin Glargine?

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.