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Lower risk Drug recall · FDA · Published July 5, 2022

Mylan Insulin Pens Missing Labels - Recalled for Safety

Mylan recalls insulin pens with missing labels to prevent medication errors. Affected pens have specific NDC numbers and were sold with expiration dates through August 2023.

🇺🇸 FDA recall #D-1292-2022DrugMylan ›
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Recalling firmMylan Pharmaceuticals Inc5005 Greenbag Rd · Morgantown, WV 26501-7124
✎ GovInfoNow plain-language explainer

Mylan is recalling insulin pens that lack labels, which could lead to incorrect dosing. This is a safety issue for people using insulin injections. Read more at govinfonow.com/recall/34438-mylan-insulin-pens-missing-labels-recalled-for-safety.

Source Summary by GovInfoNow · govinfonow.com/recall/34438-mylan-insulin-pens-missing-labels-recalled-for-safety · Updated August 18, 2026 · FDA enforcement record: FDA #D-1292-2022

Cite this page

“Mylan Insulin Pens Missing Labels - Recalled for Safety.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34438-mylan-insulin-pens-missing-labels-recalled-for-safety. Based on FDA recall #D-1292-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1292-2022%22&limit=1).

Mylan Pharmaceuticals Inc. voluntarily recalled Insulin Glargine prefilled pens on July 5, 2022, after the FDA announced that some units lacked required labeling, according to the FDA.

How to tell if you have it

  • Brand: Mylan
  • Product: Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens
  • NDC: 49502-394-71
  • Lot #: BF21002895
  • Exp. Date: Aug 2023

The hazard

The recall addresses the hazard of missing labels on some prefilled pens, which could lead to medication errors, according to the FDA.

Context

GovInfoNow's records show Mylan Pharmaceuticals Inc. has 54 other recalls on record since June 28, 2012. Recent Mylan recalls include failed dissolution specifications for Mycophenolate Mofetil Injections (Aug. 26, 2026) and Prasugrel Tablets (Aug. 17, 2026), as well as Acamprosate Tablets (July 24, 2026). Other recent recalls of similar products include CAPS TPN Bag Recall (Dec. 27, 2025) and American Regent Levocarnitine Injection Recall (April 16, 2026).

How to tell if you have this one

Check for the NDC numbers 49502-394-71 (pens) and 49502-394-75 (cartons of 5 pens). These pens were sold with an expiration date of August 2023.

  • Brand
    Mylan
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Label

    Look for a label on the pen; if missing, it is part of the recall.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Product was distributed nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 20 months after the firm started it.

1. Firm started the recall: Jul 5, 202212. FDA classified it Class I: Jul 26, 202223. Published in FDA’s Enforcement Report: Aug 3, 202234. FDA terminated the recall: Feb 26, 2024420222024
  1. Firm started the recall
  2. FDA classified it Class I
  3. Published in FDA’s Enforcement Report
  4. 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-1292-2022 (July 5, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1292-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA