Medications & Supplements/Prescription Drugs

Mylan Insulin Glargine (yfgn) Injection Pens Recalled for Missing Labels

Agency Publication Date: July 26, 2022

Summary

Mylan Pharmaceuticals Inc. is recalling 253,200 Insulin Glargine (insulin glargine-yfgn) 100 units/mL (U-100) 3 mL prefilled pens because the primary labels are missing from some individual pens. This prescription medication is used to control blood sugar in patients with diabetes, and its absence could lead to confusion about the dose or medication type. No injuries or incidents related to this issue have been reported at this time. The pens are sold in cartons containing five prefilled pens each.

Risk

Missing labels on insulin pens could cause a patient to misidentify the medication or dose, potentially leading to severe blood sugar fluctuations or serious medical complications.

What You Should Do

This recall affects Mylan Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), sold in 3 mL prefilled pens (NDC 49502-394-71) and five-pen cartons (NDC 49502-394-75).
Check your medication for lot number BF21002895 with an expiration date of August 2023. If you possess an individual pen that is missing its label, do not use it.
If you have health concerns, contact your healthcare provider or pharmacist. 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.

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 (3 mL prefilled pen)

Variants: 100 units/mL (U-100), Prefilled Pen, 5-count carton

Lot Numbers:

BF21002895 (Exp Aug 2023)

NDC:

49502-394-71

49502-394-75

Packaged in cartons of 5 prefilled pens. Manufactured by Mylan Pharmaceuticals Inc. and distributed by Mylan Specialty L.P.

Product Images

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

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90545

Status: Resolved

Manufacturer: Mylan Pharmaceuticals Inc

Sold By: Retail pharmacies; Wholesale distributors

Manufactured In: United States

Units Affected: 253,200 pens (50,650/5 per packs)

Distributed To: Nationwide

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

What You Should Do

This recall affects Mylan Insulin Glargine (insulin glargine-yfgn) Injection, 100 units/mL (U-100), sold in 3 mL prefilled pens (NDC 49502-394-71) and five-pen cartons (NDC 49502-394-75).

Check your medication for lot number BF21002895 with an expiration date of August 2023. If you possess an individual pen that is missing its label, do not use it.

If you have health concerns, contact your healthcare provider or pharmacist. 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.

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 (3 mL prefilled pen)

Variants: 100 units/mL (U-100), Prefilled Pen, 5-count carton

Lot Numbers:

BF21002895 (Exp Aug 2023)

NDC:

49502-394-71

49502-394-75

Packaged in cartons of 5 prefilled pens. Manufactured by Mylan Pharmaceuticals Inc. and distributed by Mylan Specialty L.P.