FDA announces new insulin recall due to potential labeling issue

Mylan Pharmaceuticals, a Viatris Company, is recalling one batch of its Insulin Glargine injections due to the risk of labels missing from some vials.

The batch, distributed from December 2021 to March 2022, included 10-mL vials of the company’s unbranded insulin glargine-yfgn, which is designed to control glycemic control in adult patients diagnosed with type 1 diabetes or type 2 diabetes. It can also be prescribed to pediatric patients diagnosed with type 1 diabetes.

“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,” according to an advisory on the U.S. Food and Drug Administration (FDA) website. “To date, no adverse events related to this recall have been received for this product.”

Retailers are asked to examine their inventory and discontinue the distribution of any included products. If consumers discover they have been sold an unlabeled product, they can return it.

“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,” according to the advisory.