Drug Safety Alerts

Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL Consumer-Level Recall

4/14/2022

On April 14, 2022, Mylan Pharmaceuticals Inc. issued a consumer-level recall of Insulin Glargine (Insulin glargine-yfgn) Injection, 100 units/mL NDC # 49502-0393-80. This recall was issued due to the potential for the label to be missing on some vials. The product information, batch number and expiry date information are present on the carton.

This could be a health hazard or safety risk to patients who may be using product affected by this recall.

This recall affects lot number BF21002800 exp. 08/2023. This batch was distributed by Mylan Specialty L.P. in the US between December 9, 2021, and March 4, 2022.

For patients receiving treatment with more than one type of insulin (e.g., both short and long-acting insulin), a missing label on Insulin Glargine vials could lead to a mix-up of products/strengths, which may result in less optimal glycemic control (either high or low blood sugar) which could result in serious complications. To date, no adverse events related to this recall have been received for this product.

Insulin Glargine is 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.

CVS Caremark® Response:

Please note: This product is not carried by the CVS Caremark® Mail Service Pharmacies.

For more information, please call Viatris Customer Relations at 1-800-796-9526, Monday through Friday, 8:00 AM to 5:00 PM (ET) or email customer.service@viatris.com.

You may also call the United States Food and Drug Administration (FDA) at 1‑888‑INFO‑FDA (1‑888‑463‑6332) or visit https://www.fda.gov.