Batch of Insulin Pens Recalled Due to Missing Label

Dozens of insulin pens are being recalled due to missing labels that could result in "serious complications." Mylan Pharmaceuticals Inc., affiliated to healthcare company Viatris Inc., on Jan. 18 issued a voluntary recall of one batch of its non-interchangeable Semglee (insulin glargine injection), 100 units/ml (U-100), 3mL prefilled pens due to the potential for a missing label "on some prefilled pens within a labelled carton for this particular batch," according an U.S. Food and Drug Administration (FDA) recall notice posted on Jan. 19.

Although Mylan Pharmaceuticals Inc. has not received any reports of adverse events related to the recall, the FDA recall noticed noted that the products with missing labels could potentially result in serious complications. According to the risk statement, a missing label on the prefilled pens for patients receiving treatment with more than one type of insulin "could lead to a mix-up of products/strengths, resulting in administration of the wrong insulin." The administration of the wrong insulin, according to the notice, "could result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications."

The recalled products, "a long-acting human insulin analog indicated to improve glycemic control in adults and pediatric patients with type 1 diabetes mellitus and in adults with type 2 diabetes mellitus," include 3mL Prefilled Pen under batch BF20003118 and expiry date of August 2022. The Semglee prefilled pens are packaged in a labelled carton of five pens. The affected batch was manufactured by Biocon Sdn Bhd. and distributed by Mylan Specialty L.P. in the U.S. between May 11 and November 11, 2021. Consumers can identify the recalled products by prefilled pens missing a white label with the product name and dosage information affixed around the pen.


After learning of the missing labels, the company initiated the recall of batch BF20003118 and notified its distributors and retailers by letter. The company is also said to be arranging for return of all recalled products. Consumers who have purchased the recalled products are being asked to contact Stericycle at 1-888-843-0255 for the documentation packet to return product to Stericycle. Consumers with questions regarding the recall can contact Viatris Customer Relations by 800-796-9526 or, Monday through Friday from 8 a.m. – 5 p.m. ET. Meanwhile, both wholesalers and retailers are being advised to "immediately" examine their inventory, quarantine, and discontinue distribution of this batch. The full recall notice can be found by clicking here.