The Recall Desk
SevereFDA (Drugs)·D-0009-2022·Announced 2021-10-20

Glucagon Emergency Kit Recall: Subpotent Drug in Vials

Eli Lilly is recalling Glucagon Emergency Kits (Lot #D239382D, expiration April 2022) because some vials contain liquid instead of powder and do not deliver the full expected drug effect when administered.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This recall is FDA Class I, which establishes a minimum severity of 4 per the rubric. The defect involves a critical emergency medication that fails to deliver its intended therapeutic effect, posing serious risk to diabetic patients who depend on glucagon for life-threatening hypoglycemic episodes.

Plain-English summary

Eli Lilly & Company is recalling Glucagon Emergency Kits for Low Blood Sugar (1 mg glucagon for injection per vial with diluent syringe, NDC 0002-8031-01) due to subpotency. Affected lot number D239382D (expiration date April 2022) consists of approximately 19,174 syringes distributed nationwide in the USA and Puerto Rico, as well as in Canada, Argentina, Costa Rica, and Mexico.

The defect involves vials that contain a liquid substance instead of the expected powder form. Upon administration, these affected vials lack the full drug effect necessary for treating low blood sugar emergencies. Glucagon is a critical rescue medication for patients with diabetes who experience severe hypoglycemia.

Patients and healthcare providers who have received this lot should not use the affected kits. Patients requiring emergency glucagon treatment should ensure they have a functioning emergency kit from a different lot and consult their healthcare provider. Anyone who has used a glucagon kit from lot D239382D and experienced an inadequate response should seek immediate medical attention.

The recalled product

Product
Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluent for Glucagon, 1 mL syringe. Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285; Glucagon, NDC: 0002-8031-01
Manufacturer
Eli Lilly & Company
Hazard
  • subpotent-drug
  • lack-of-drug-effect

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: D239382D
  • Exp. Date April 2022

Distribution

Distributed nationwide across the United States.