Eli Lilly Recall: Glucagon Emergency Kit May 'Fail To Treat' Low Blood Sugar

The FDA's headquarters and home of the Center for Drug Evaluation and Research in Silver Spring, Maryland.

Eli Lilly is voluntarily recalling a specific lot of its Glucagon Emergency Kit because of "loss of potency." It may not treat severe low blood sugar, which can lead to adverse health effects.

The problem was discovered after the company received a complaint that the contents of the vials were in liquid form instead of powder, the company announcement posted on the U.S. Food and Drug Administration (FDA) website noted. Investigation revealed that the issue may be "related to the manufacturing process." Using the product in this liquid form may "fail to treat" severe low blood sugar due to the loss of potency, the announcement noted.

Glucagon is an anti-hypoglycemic agent that's used to treat very low blood sugar (severe hypoglycemia) in people with diabetes. Things like missing a meal or exercising too much can lead to low blood sugar, the company noted, and mild or moderate low blood sugar can become very low blood sugar if not treated immediately. In these cases, a patient may lose consciousness or be physically unable to eat the necessary source of sugar so a Glucagon injection may be needed.

"Severe hypoglycemia in patients with diabetes, if not reversed, can potentially cause adverse health consequences ranging from transient, minor complaints to neurological damage, seizures, and even death if not promptly treated," the company noted in the risk statement. "Associated with the one product complaint, it was reported to Lilly that the involved patient experienced lack of drug effect and also reported subsequent seizures."

The recall affects lot D239382D with the expiration date of April 2022 (04 2022). It was distributed to retailers and wholesalers nationwide, and the company is already contacting the distributors and customers to arrange for a return and replacement.

Images of the affected product are available on the FDA website.

Customers who may have a Glucagon Emergency Kit lot D239382D are being advised to contact the company at 1-800-LILLYRX (1-800-545-5979) for instructions on how to have the product returned and replaced. They are also advised to contact their health care provider if they have had any problems that may possibly be related to using the product.

"Lilly is deeply committed to manufacturing high-quality medicines for patients who need them, and the safety and quality of our products is our highest priority," the company said. "We take our obligations seriously and have rigorous quality systems in place to ensure compliance with stringent regulatory requirements."