Mylan recalls diabetes med after labeling error

Jan. 21, 2022

Mylan Pharmaceuticals is voluntarily pulling one batch of Semglee —100 units/ml, 3mL— a non-interchangeable insulin glargine injection, due to the potential for missing labels on some of the prefilled pens, which are packaged in a labeled carton of five pens, the company announced.   

The recalled batch was manufactured by Biocon Sdn Bhd, Asia’s largest integrated insulin manufacturing and R&D facility, and distributed by Mylan subsidiary, Mylan Specialty, in the U.S. between May 11, 2021, and November 11, 2021. The recalled batch is as follows: 


Name and Strength





Semglee® (insulin glargine injection),

100 units/mL (U-100)

3mL Prefilled Pen


August 2022

The recall does not apply to the recently launched interchangeable biosimilars of Semglee, a branded product, or Insulin Glargine, an unbranded product. The interchangeable biosimilar Semglee was approved on July 28 by the U.S. FDA as the first product of its kind on the market. It was hailed for its potential to increase competition in the market and lower the cost of insulin. 

Botched pens can be identified by their lack of a white label with the product name and dosage information affixed around the pen. Mylan has begun the recall of the faulty batch. Distributors and retailers have been made aware of the situation. 

Since Semglee is a long-acting human insulin analog, Mylan, a Viatris company, says the mixup could cause serious consequences for patients receiving more than one type of insulin treatment resulting in complications from blood sugar levels being too high or too low.