US Recall News

United States Recall News Alerts for Recalled Drugs, Food, Products, & Vehicles

MENUMENU
  • Home
  • About
    • Advertise
  • Full Recall News Archive
    • Top Story

      J&J Settles Talc Mesothelioma Settlement

      By Sandra Dalton, Staff Writer On January 6, 2020, Superior Court Judge Stephen Kaus announced that Johnson & Johnsons (J&J) had agreed to … [Read More...]

      Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”

      Summary Company Announcement Date: July 10, 2025 FDA Publish Date: July … [Read More...]

    • More Safety Articles
    • Federal Preemption of State Product Liability Law
  • Drug Recalls
    • Abilify
    • Benicar
    • Fluoroquinolones
    • Invokana
    • Lipitor
    • Nuplazid
    • Opioids
    • OxyContin
    • Pradaxa
    • Proton Pump Inhibitors (PPIs)
    • Risperdal
    • SSRI
    • Symptoms & Side Effects
    • Taxotere
    • Testosterone
    • Uloric
    • Valsartan
    • Xarelto
    • Zofran
  • Medical Devices
    • 3M Earplug
    • 3T Heater-Cooler System
    • Bair Hugger
    • Bipolar Hip System
    • Essure
    • Hip Replacements
    • Implanon
    • IVC Filters
    • Hernia Mesh
    • Power Morcellators
    • Shoulder Implants
    • Transvaginal Mesh
  • Food Recalls
    • FDA Press Releases
    • USDA Press Releases
  • Auto Recalls
    • Air Bags
    • Ignitions
    • NHTSA Press Releases
    • Off-Road Utility Vehicles
    • Snowmobiles
    • Tires
  • Other Products
    • Asbestos
    • Baby Products
    • Pet Products
    • Roundup
    • Talcum Powder
    • Toy Recalls
You are here: Home / Food Recalls / FDA Press Releases / Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels on Some Pens

Mylan Pharmaceuticals Inc., a Viatris Company, Issues Voluntary Nationwide Recall of One Batch of Insulin Glargine (Insulin glargine-yfgn) Injection Pens, 100 units/mL (U-100), Due to the Potential of Missing Labels on Some Pens

July 4, 2022 By The FDA Leave a Comment

Summary

Company Announcement Date:
July 05, 2022
FDA Publish Date:
July 06, 2022
Product Type:
Drugs

Reason for Announcement:

Recall Reason Description

Potential for the label to be missing on some pens.

Company Name:
Mylan Pharmaceuticals Inc.
Brand Name:

Brand Name(s)

Mylan Pharmaceuticals Inc.

Product Description:

Product Description

Insulin Glargine (Insulin glargine-yfgn) Injection Pens


Company Announcement

FOR IMMEDIATE RELEASE – PITTSBURGH – July 5, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL (U-100), 3 mL prefilled pens which are packaged in cartons of five pens to the consumer level. This product is not the branded Semglee® pen but the unbranded Insulin Glargine-yfgn pens. This batch is being recalled due to the potential for the label to be missing on some pens.

Risk Statement: For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine pens could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no adverse events related to this recall have been received for this product.

This recall pertains only to the unbranded interchangeable biosimilar Insulin Glargine-yfgn pens and does not impact the branded interchangeable biosimilar Semglee® (insulin glargine-yfgn) injection pens.

This product is a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus. The product is packaged in a 3 mL prefilled pen which is then packaged in cartons of five pens. The product information, batch number and expiry date information are present on the carton.

This batch was manufactured by Biocon Sdn. Bhd. and was distributed by Mylan Specialty L.P. in the US between April 4, 2022 and May 5, 2022. The recalled batch information is as follows:

NDC # Name and Strength Size Batch # Expiry
49502-394-75 Insulin Glargine (Insulin glargine-yfgn)
Injection, 100 units/mL (U-100)
3 mL Prefilled Pen BF21002895 Aug 2023

The company has initiated the recall of batch BF21002895 by notifying its distributors and retailers by letter and arranging for return of all recalled products. Following are actions for wholesalers, retailers and consumers:

  • Wholesalers: Immediately examine your inventory, quarantine, and discontinue distribution of the batch subject to recall. In addition, if you have further distributed the product, please identify all customers, including retail level customers, and provide a list via Microsoft Excel file to mylan8775@sedgwick.com within five (5) business days. Sedgwick will notify your retail level customers that received the affected batch.
  • Retailers: Immediately examine your inventory, quarantine and discontinue distribution of this batch. In addition, if you have further distributed the subject batch, please identify the consumer and notify them of this product recall and to immediately return any unlabeled product per the instructions below.
  • Consumers: If you have an unlabeled pen, please contact Sedgwick at 1-877-643-8438 for the documentation packet to return the product.

Consumers with questions regarding this recall can contact Viatris Customer Relations by phone at 1-800-796-9526 or by email at customer.service@viatris.com, Monday through Friday from 8 a.m. – 5 p.m. EST. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

About Viatris
Viatris Inc. (NASDAQ: VTRS) is a new kind of healthcare company, empowering people worldwide to live healthier at every stage of life. We provide access to medicines, advance sustainable operations, develop innovative solutions and leverage our collective expertise to connect more people to more products and services through our one-of-a-kind Global Healthcare Gateway®. Formed in November 2020, Viatris brings together scientific, manufacturing and distribution expertise with proven regulatory, medical, and commercial capabilities to deliver high-quality medicines to patients in more than 165 countries and territories. Viatris’ portfolio comprises more than 1,400 approved molecules across a wide range of therapeutic areas, spanning both non-communicable and infectious diseases, including globally recognized brands, complex generic and branded medicines, a portfolio of biosimilars and a variety of over-the-counter consumer products. With a global workforce of approximately 37,000, Viatris is headquartered in the U.S., with global centers in Pittsburgh, Shanghai and Hyderabad, India. Learn more at viatris.com and investor.viatris.com, and connect with us on Twitter at @ViatrisInc, LinkedIn and YouTube.

Contacts:

Media:

+1.724.514.1968
Communications@viatris.com

Kimberly Wise
kimberly.wise@viatris.com

Investors:

+1.724.514.1813
InvestorRelations@viatris.com

Bill Szablewski
William.Szablewski@viatris.com


Company Contact Information


Product Photos

  • Mylan, Insulin Glargine (Insulin glargine-yfgn) Injection 100 units/mL (U100), 3 mL Prefilled Pens
  • Mylan, Insulin Glargine (Insulin glargine-yfgn) Injection 3 mL Prefilled Pens, showing location of UPC, Lot Code and Expiration information

Share this:

  • Click to share on Facebook (Opens in new window) Facebook
  • Click to share on X (Opens in new window) X
  • Click to share on LinkedIn (Opens in new window) LinkedIn
  • Click to email a link to a friend (Opens in new window) Email
  • Click to print (Opens in new window) Print

Related

Filed Under: FDA Press Releases

About The FDA

The Food and Drug Administration (FDA) is an agency within the U.S. Department of Health and Human Services. It consists of the Office of the Commissioner and four directorates overseeing the core functions of the agency: Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.

Leave a ReplyCancel reply

This site uses Akismet to reduce spam. Learn how your comment data is processed.

Facebook
Thomas Roney LLC
Economic Consulting

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”

July 10, 2025 By The FDA

Walmart Recalls Ozark Trail 64 oz Water Bottles Due to Serious Impact and Laceration Hazards

July 9, 2025 By The CPSC

WLIVE Fabric Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violations of Federal Standard for Clothing Storage Units; Sold on Amazon by WLIVE

July 9, 2025 By The CPSC

Hero Highlight

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

AUGNORYE Padded Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by YIXIA

July 9, 2025 By The CPSC

Braided Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by Haoyunm

July 9, 2025 By The CPSC

Creekliybear Play Yard Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violates Mandatory Standard for Crib Mattresses; Sold on Amazon by Kbabyea

July 9, 2025 By The CPSC

Dearlomum Retractable Safety Gates Recalled Due to Risk of Serious Injury or Death to Children from Entrapment Hazard; Violates Federal Standard for Gates and Enclosures; Sold on Amazon by Signbaby

July 9, 2025 By The CPSC

CHS Inc. Recalls Payback Champion Lamb Feed Due to Elevated Copper Health Risk

July 9, 2025 By The FDA

J&J Settles Talc Mesothelioma Settlement

January 15, 2020 By Advice Media

Dearlomum Retractable Safety Gates Recalled Due to Risk of Serious Injury or Death to Children from Entrapment Hazard; Violates Federal Standard for Gates and Enclosures; Sold on Amazon by Signbaby

July 9, 2025 By The CPSC

CHS Inc. Recalls Payback Champion Lamb Feed Due to Elevated Copper Health Risk

July 9, 2025 By The FDA

Mondelēz Global LLC Conducts U.S. Voluntary Recall of Four Carton Sizes of RITZ Peanut Butter Cracker Sandwiches Due to Labeling Error

July 8, 2025 By The FDA

Recall News in Your Inbox

Enter your email address to receive automated recall news updates.

Recent Comments

  • Roger McGowan on ABH NATURE’S PRODUCTS, INC, ABH PHARMA, INC., and STOCKNUTRA.COM, INC. Issues Nationwide Recall of All Lots of Dietary Supplement Products
  • Kathryn Moore on FDA Wants Cancer Warning on Breast Implants
  • BRAD on Huge ATV Recall by Polaris – Sportsman and Scrambler
  • Crystal Anderson on Allergan Voluntarily Recalls BIOCELL® Textured Breast Implants and Tissue Expanders
  • Outsourcing Training on The Modern Marketing of Pain
  • SANDRA Collett on Processed Food Preservative Linked to Autism?
  • Eric Karsh on Health Risks of Roundup Go Well Beyond Cancer

Recent Posts

  • Hartford Bakery, Inc. Issues Allergy Alert on Undeclared Hazelnuts in “Lewis Bake Shop Artisan Style ½ Loaf”
  • Walmart Recalls Ozark Trail 64 oz Water Bottles Due to Serious Impact and Laceration Hazards
  • WLIVE Fabric Dressers Recalled Due to Risk of Serious Injury or Death from Tip-Over and Entrapment Hazards; Violations of Federal Standard for Clothing Storage Units; Sold on Amazon by WLIVE
  • Giant Bicycle Recalls Momentum Vida E+ E-Bikes Due to Crash Hazard
  • SPPTTY Kids Bicycles Recalled Due to Risk of Death or Injury from Lead Poisoning; Violates Federal Lead Content Ban; Sold at Walmart by Shenzhen Yihuachuang Technology
  • AUGNORYE Padded Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by YIXIA
  • Braided Crib Bumpers Recalled Due to Risk of Serious Injury or Death from Suffocation; Violates Federal Crib Bumper Ban; Sold on Amazon by Haoyunm
  • Creekliybear Play Yard Mattresses Recalled Due to Risk of Serious Injury or Death from Entrapment Hazard; Violates Mandatory Standard for Crib Mattresses; Sold on Amazon by Kbabyea
  • Dearlomum Retractable Safety Gates Recalled Due to Risk of Serious Injury or Death to Children from Entrapment Hazard; Violates Federal Standard for Gates and Enclosures; Sold on Amazon by Signbaby
-- See More Recall News

Disclaimer: The information contained in these topics is not intended nor implied to be a substitute for professional medical or legal advice, it is provided for educational purposes only. Always seek the advice of your physician or other qualified healthcare provider about any questions you may have regarding a medical condition. Nothing contained in these topics is intended to be used for medical diagnosis or treatment.


ATTORNEY ADVERTISING. The information provided on this website is not legal advice. No attorney-client relationship is formed by the use of this site. It is not stated or implied that a lawyer is certified as a specialist in any particular field of law. No results are guaranteed, and prior results do not guarantee a similar outcome. This site is informational, only, not dispositive; it is up to you to decide whether a particular lawyer is right for you. Use of this site is subject to your agreement to these.


Copyright © 2025 Altrumedia · Terms of Service · Log in