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January 19, 2022 – Mylan Pharmaceuticals, a Viatris company, has recalled one batch of non- interchangeable Semglee® (insulin glargine injection), 100 units/mL (U-100) 3mL prefilled pens, which are packaged in a carton of five pens. Some pens within the carton may be missing a label. The recall does not affect Mylan's recently launched automatically interchangeable Semglee® (insulin glargine-yfgn) injection, which pharmacists can substitute for Lantus® (insulin glargine – Sanofi) without a new prescription.
- There is no impact to members through Benecard Central Fill.
- Semglee is indicated to improve glycemic control in adults who have type 1 or type 2 diabetes and pediatric patients who have type 1 diabetes. Pens with missing labels could be confused for the wrong insulin if a patient is using more than one insulin product. This could cause high or low blood sugar with potentially serious complications.
- As of the recall date, Mylan has received no reports of serious adverse events related to use of the affected product. The recalled Semglee belongs to batch BF20003118 and has an expiration date of August 2022.
- Consumers who have unlabeled Semglee pens in their possession can contact Stericycle at 1-888- 843-0255 to arrange product returns. Questions regarding the recall should be directed to Viatris Customer Relations at 1-800-796-9526 or customer.service@viatris.com. Mylan recommends consumers contact their healthcare provider if they have experienced any problems that may be related to using the recalled product.
- Additional information is available on the U.S. FDA's website.