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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Affected units
- 19,174
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
Related recalls
Same manufacturer · Eli Lilly & Company
See all →- HighEli Lilly Recalls Humalog Sterile Diluent Due to Manufacturing Deviations
FDA (Drugs) · 2024-04-24
- SevereTrulicity autoinjector pens recalled for incorrect strength labeling
FDA (Drugs) · 2021-09-01
- ModerateZyprexa Intramuscular Injection Recalled for Manufacturing Defects
FDA (Drugs) · 2021-08-18
Same hazard · subpotent drug
See all →- SeverePfizer Recalls Levoxyl Tablets Due to Subpotent Drug Levels
FDA (Drugs) · 2026-10-28
- LowImprimisRx Recalls Subpotent Povidone Iodine and Proparacaine Ophthalmic Solution
FDA (Drugs) · 2026-09-16
- ModerateAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Recalls Subpotent Levothyroxine Sodium Tablets Nationwide
FDA (Drugs) · 2026-09-02
- HighAccord Healthcare Recalls Subpotent Levothyroxine Sodium Tablets
FDA (Drugs) · 2026-09-02
Similar recalls
- HighGlucagon Emergency Kit Recalled for Temperature Abuse During Manufacturing
FDA (Drugs) · 2022-06-15
- SevereGlucagon Emergency Kit Recalled for Manufacturing Process Deviation
FDA (Drugs) · 2026-07-08
- HighGlucaGen Glucagon Injection Recalled for Temperature Control Deviations
FDA (Drugs) · 2022-06-15
- HighGlucagen Injectable Medication Recalled Nationwide for Temperature Abuse
FDA (Drugs) · 2022-06-15
- HighEli Lilly Recalls Humalog Sterile Diluent Due to Manufacturing Deviations
FDA (Drugs) · 2024-04-24
- CriticalInsulin Glargine Injection Vials Recalled Due to Missing Labels
FDA (Drugs) · 2022-05-04