CLASS I Drug recall · Reported 20 Oct 2021 · FDA Enforcement Report
Glucagon Emergency Kit for Low Blood Sugar, Glucagon recalled
Eli Lilly is recalling Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial, distributed nationwide in the US. The recall was initiated on 24 Sep 2021 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0009-2022
- FDA event ID
- 88764
- Recalling firm
- Eli Lilly, Indianapolis, IN
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 24 Sep 2021
- FDA classified
- 14 Oct 2021
- Reported
- 20 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 24 Sep 2021 | Recall initiated by company | |
| 14 Oct 2021 | Classified by FDA | +20 days |
| 20 Oct 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide with the USA and Puerto Rico; Canada, Argentina, Costa Rica, Mexico
Questions about this recall
Why was it recalled?
SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.
Which lots are affected?
Lot #: D239382D, Exp. Date April 2022
Where was it sold?
Nationwide with the USA and Puerto Rico; Canada, Argentina, Costa Rica, Mexico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Eli Lilly
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|---|---|---|---|---|---|
| Drug | CLASS II | Sterile Diluent, Humalog U-100 (insulin lispro injection) recalledHumalog | Eli Lilly | Manufacturing (CGMP) Deviations | Nationwide |
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| Drug | CLASS II | Zyprexa Intramuscular, Olanzapine for Injection recalled by Eli Lilly & | Eli Lilly | Manufacturing (CGMP) Deviations | IN, MS, OH |
| Drug | CLASS III | Erbitux Cetuximab Injection, 200 mg/ (2 mg/mL) per single-use vial recalledErbitux | Eli Lilly | Labeling Errors | 11 states |