Medications & Supplements/Prescription Drugs

Semglee (insulin glargine) Injection Recalled for Missing Product Labels

Agency Publication Date: January 28, 2022

Summary

Mylan Pharmaceuticals Inc. has recalled 73,175 prefilled pens of Semglee (insulin glargine) injection, 100 units/mL (U-100), because some pens may be missing their product labels. This missing information makes it difficult for patients to identify the medication and strength, which could lead to administration errors. No incidents or injuries have been reported to date.

Risk

Without a label, users cannot verify they are using the correct insulin or the correct dose, which could lead to high or low blood sugar levels. This poses a significant risk for patients who rely on accurate insulin administration to manage their diabetes.

What You Should Do

The recalled product is Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pens with batch number BF20003118 and an expiration date of August 2022.
Check the batch number and expiration date printed on your pen or the carton (NDC 49502-0196-71 for individual pens or NDC 49502-0196-75 for the carton).
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 the manufacturer 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: Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pen

Variants: 100 units/mL (U-100), 3 mL Prefilled Pen, Rx Only

Lot Numbers:

BF20003118 (Exp. August 2022)

NDC:

49502-0196-71

49502-0196-75

Manufactured in Malaysia for Mylan Specialty L.P.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89357

Status: Resolved

Manufacturer: Mylan Pharmaceuticals Inc

Sold By: pharmacies

Manufactured In: United States, Malaysia

Units Affected: 73,175 prefilled pens

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 · 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

The recalled product is Semglee (insulin glargine) injection, 100 units/mL (U-100), 3 mL Prefilled Pens with batch number BF20003118 and an expiration date of August 2022.

Check the batch number and expiration date printed on your pen or the carton (NDC 49502-0196-71 for individual pens or NDC 49502-0196-75 for the carton).

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 the manufacturer for further instructions.

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