Mylan Semglee insulin pens: Missing label in some prefilled pens
Mylan recalls Semglee (insulin glargine) prefilled pens with missing labels. Check your product's NDC 49502-0196-71 or 49502-0196-75 for affected units. No immediate action needed but label verification is critical for safe use.
Lower-risk recall
Labeling: Missing Label: label missing from some Semglee prefilled pens.
Contact the company
What happened, in plain English
Mylan is recalling Semglee insulin pens that may have missing labels. This could lead to incorrect dosing if the label is not visible, which is important for people using insulin injections. Read more at govinfonow.com/recall/35397-mylan-semglee-insulin-pens-missing-label-in-some-prefilled-pens.
Source Summary by GovInfoNow · govinfonow.com/recall/35397-mylan-semglee-insulin-pens-missing-label-in-some-prefilled-pens · Updated August 17, 2026 · FDA enforcement record: FDA #D-0462-2022
Cite this page
“Mylan Semglee insulin pens: Missing label in some prefilled pens.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/35397-mylan-semglee-insulin-pens-missing-label-in-some-prefilled-pens. Based on FDA recall #D-0462-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0462-2022%22&limit=1).
Why it’s dangerous
Missing labels could cause users to misread the insulin dose or expiration date, potentially leading to incorrect dosing. However, the hazard is not described as causing immediate injury or serious harm in normal use.
Who’s affected
People with diabetes who use Semglee insulin pens. Those with the specific NDC numbers 49502-0196-71 or 49502-0196-75 are most at risk.
How to tell if you have this one
Check for the NDC numbers 49502-0196-71 (pens) or 49502-0196-75 (cartons) on the product packaging. The pens are labeled as Semglee insulin glargine 100 units/mL, 3 mL prefilled.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Label Visibility
Look for the label on the pen; if missing, do not use it.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Thailand.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2 years after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class I
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0462-2022 (January 5, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0462-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.