Medications & Supplements/Prescription Drugs

Insulin Glargine Injection Recalled Due to Missing Vial Labels

Agency Publication Date: April 26, 2022

Summary

Mylan Pharmaceuticals Inc. is recalling approximately 89,665 vials of Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100). The recall was issued because some 10 mL multiple-dose vials may be missing their individual product labels. This prescription medication is packaged in a carton, and while the carton may be labeled correctly, the vial inside could be completely blank. No injuries or incidents have been reported to date.

Risk

A missing label on a vial of insulin poses a critical safety risk because it can lead to medication errors and mix-ups with other insulins or drugs. If a patient uses the wrong product or an incorrect dose, they may experience life-threatening blood sugar complications, including dangerously high blood sugar (hyperglycemia) or low blood sugar (hypoglycemia).

What You Should Do

This recall involves Mylan's Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), sold in 10 mL multiple-dose vials. Affected cartons are marked with NDC 49502-393-80, lot number BF21002800, and an expiration date of 8/2023.
Open the carton and check the individual vial inside to ensure it has a complete and legible product label. If the vial is missing a label, do not use it, as you cannot verify the medication or dosage.
If you have health concerns or think you may have used an unlabeled product, contact your healthcare provider or pharmacist immediately. Return any unused product to the place of purchase for a refund, throw it away, or contact Mylan Pharmaceuticals Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Insulin Glargine (insulin glargine-yfgn) Injection (10 mL)by Mylan

Variants: 100 units/mL (U-100), Multiple-Dose Vial, Rx Only

Lot Numbers:

BF21002800 (Exp 8/2023)

NDC:

49502-393-80

Quantity: 89,665 vials affected. Recall #: D-0845-2022.

Product Images

Labeling, Insulin Glargine Injection

Labeling, Box, Insulin Glargine Injection

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89970

Status: Resolved

Manufacturer: Mylan Pharmaceuticals Inc

Sold By: pharmacies; healthcare providers

Manufactured In: United States, Malaysia

Units Affected: 89,665 vials

Distributed To: Nationwide

Agency Last Updated: May 4, 2022

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · FDA Press Release · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall involves Mylan's Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), sold in 10 mL multiple-dose vials. Affected cartons are marked with NDC 49502-393-80, lot number BF21002800, and an expiration date of 8/2023.

Open the carton and check the individual vial inside to ensure it has a complete and legible product label. If the vial is missing a label, do not use it, as you cannot verify the medication or dosage.

If you have health concerns or think you may have used an unlabeled product, contact your healthcare provider or pharmacist immediately. Return any unused product to the place of purchase for a refund, throw it away, or contact Mylan Pharmaceuticals Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.