---
title: "Semglee: Insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens — FDA announcement Jan 19, 2022 | Is It on Recall"
description: "Missing Label"
url: https://isitonrecall.com/recall/fdapress-bbf8ff92f8be4ec9-semglee-insulin-glargine-injection-100-units-ml-u-100-3ml-prefilled-pens/
updated: 2026-10-01
site: "Is It on Recall"
language: en
---

[Recall archive](https://isitonrecall.com/archives/) / FDA company announcement

# Semglee: Insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens — FDA announcement Jan 19, 2022

Reported terminated

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Jan 19, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/).

## What the record says

- **Product**: Insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens
- **Reason**: Missing Label
- **Classification**: Not supplied
- **Recalling firm**: Mylan Pharmaceutical Inc.
- **Quantity**: Not supplied
- **Agency-reported status**: Terminated in FDA listing
- **Source record identifier**: bbf8ff92f8be4ec9

[Open the official record](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-recall-one-batch-semgleer-insulin)

## Lot and product identifiers

| Label field | Details supplied by the agency |
| --- | --- |
| Lot, code or applicability | PITTSBURGH – Jan. 18, 2022 – Mylan Pharmaceuticals Inc., a Viatris company, is voluntarily recalling one batch of its non-interchangeable Semglee® (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens, which are packaged in a labelled carton of five (5) pens. The product is being recalled due to the potential for the label to be missing on some prefilled pens within a labelled carton for this particular batch.; This batch was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty L.P. in the U.S. between May 11, 2021 and November 11, 2021. The recalled lot is as follows:; The company has initiated the recall of batch BF20003118 and notified its distributors and retailers by letter and is arranging for return of all recalled products. Following are actions for wholesalers, retailers and consumers:; Wholesaler: Immediately examine your inventory, quarantine, and discontinue distribution of this lot. In addition, if you have further distributed the product, please identify your retail level customers and provide a list of customers via Microsoft excel file to mylan6069@sedgwick.com within 10 business days. Stericycle will notify your retail level customers that received the affected batch.; Retailer: Immediately examine your inventory, quarantine, and discontinue distribution of this batch.; NDC # \| Name and Strength \| Size \| Batch# \| Expiry; 49502-196-75 \| Semglee® (insulin glargine injection), 100 units/mL (U-100) \| 3mL Prefilled Pen \| BF20003118 \| August 2022 |

Match all identifying details in the current notice. A brand name alone is not enough.

## Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

**FDA company announcement, table 1**

| NDC # | Name and Strength | Size | Batch# | Expiry |
| --- | --- | --- | --- | --- |
| 49502-196-75 | Semglee® (insulin glargine injection), 100 units/mL (U-100) | 3mL Prefilled Pen | BF20003118 | August 2022 |

Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-recall-one-batch-semgleer-insulin).

## Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

## Dates in the source

- **Fda listing date**: Jan 19, 2022
- **Company announcement date**: Jan 18, 2022

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

## What to do next

Consumers with questions regarding this recall can contact Viatris Customer Relations by 800-796-9526 or 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.

[Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/mylan-pharmaceuticals-inc-viatris-company-conducting-voluntary-recall-one-batch-semgleer-insulin)

## Before changing a medicine

Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine.

Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do)

## Related records

[Medications records](https://isitonrecall.com/category/medications/) [Mylan Pharmaceutical Inc. records](https://isitonrecall.com/brand/mylan-pharmaceutical-inc/)