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.
Labeling: Missing Label: label missing from some Semglee prefilled pens.
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.
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.
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.
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.
Look for the label on the pen; if missing, do not use it.
No immediate stop is needed, but if the label is missing, do not use the pen.
NDC 49502-0196-71 (pens) and NDC 49502-0196-75 (cartons).
The recall states missing labels could lead to incorrect dosing, but it does not describe a risk of serious injury in normal use.
We’ve drafted a message you can send Mylan to request your refund or repair — edit it as you like.
Subject: Recall D-0462-2022 — Mylan Mylan Hello, I own a Mylan that is covered by recall D-0462-2022 from Mylan. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
