Mylan Pharmaceuticals, one of several manufacturers of insulin glargine, is conducting a voluntary nationwide recall of one batch of the product, as noted in an announcement from the U.S. Food and Drug Administration (FDA).
Insulin glargine is the generic name for a long-acting form of insulin originally sold under the brand name Lantus, which is a trademark of the insulin manufacturer Sanofi. Sanofi’s primary U.S. patents for insulin glargine expired in 2015, which opened the door for other drugmakers to manufacture and market competing versions of this type of insulin. Unlike standard generic drugs, though, competing versions of insulin glargine aren’t exactly identical, on a molecular level, to the original version — like other biologic drugs, all types of insulin are large, complex molecules that will vary somewhat based on manufacturing practices. In practice, this means that creating a competing version of a form of insulin may be more difficult — both on a technical level, and when it comes to getting FDA approval — than creating a competing generic version of a nonbiologic drug.
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Nevertheless, a couple of companies have entered the U.S. market for insulin glargine in the past few years — including Lilly (selling it under the brand name Basaglar) and Mylan (selling it under the brand name Semglee). Mylan then also added an unbranded version of insulin glargine to its product lineup, which is identical to Semglee except for the label.
One batch of unbranded insulin glargine affected
The latest recall applies to only one batch of unbranded insulin glargine from Mylan — this batch does not carry the Semglee name. This batch of 10-milliliter vials, which are then packaged in a carton when shipped to pharmacies, are labeled as “insulin glargine-yfgn,” which is the official name for Mylan’s version of insulin glargine. The only reason why this batch is being recalled is that the label may be missing on some vials, which could lead to a pharmacist dispensing one of these vials without noticing that the label is missing. Needless to say, receiving a vial of insulin that doesn’t have any label could be confusing or even dangerous for someone with diabetes who uses more than one type of insulin. But as long as the person knows what type of insulin it is and how to use it, there is no reason to believe that any of the insulin affected by the recall is actually unsafe or compromised in any way.
According to the FDA, the affected batch was manufactured by Biocon Sdn. Bhd. and distributed by Mylan Specialty L.P. in the United States between December 9, 2021, and March 4, 2022. The batch number is BF21002800, and it expires in August 2023.
While the FDA recall notice explains the potential for a mix-up in people who use more than one insulin type — with potentially serious health consequences — there have been no reported adverse events related to the affected batch of insulin glargine.
If you have an unlabeled vial of insulin glargine affected by this recall, contact Stericycle (which is administering the recall for Mylan) at (888) 912-7084 to receive a documentation packet for returning the product.