PlainRecalls
CriticalClass ITerminated

FDA Drug recall · Reported October 20, 2021

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

SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also a lack of full drug effect upon administration.

Recall #
D-0009-2022
Affected scope
19,174 syringes
Initiated
September 24, 2021
Verify with FDA Drug →
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Eli Lilly & Company recalled Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluen… - a critical-severity action.

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per vial; Diluen… was recalled by Eli Lilly & Company in October 20, 2021. Reason: SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also …. Check the official notice for the remedy. Verify recall #D-0009-2022 with the FDA Drug before acting.

The recall

Eli Lilly & Company issued this critical-severity FDA Drug recall-SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. There was also ….

Critical
severity level
Class I
classification
October 20, 2021
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0009-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 6 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,472 drugs & medications recalls on record

05001,0001,5002,000 2006201220152018202120242026 448
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Product description

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

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.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Terminated
Recall number D-0009-2022
Date reported October 20, 2021
Date initiated September 24, 2021
Recalling firm Eli Lilly & Company
Firm location Indianapolis, IN
Affected scope 19,174 syringes
Distribution Nationwide with the USA and Puerto Rico; Canada, Argentina, Costa Rica, Mexico

Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (D-0009-2022) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
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. Recalled by Eli Lilly & Company. Units affected: 19,174 syringes.
Why was this product 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 agency issued this recall?
This recall was issued by the FDA Drug on October 20, 2021. Severity: Critical. Recall number: D-0009-2022.
Where was the recalled product distributed?
Distribution: Nationwide with the USA and Puerto Rico; Canada, Argentina, Costa Rica, Mexico.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

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This recall: FDA Drug, reported October 20, 2021. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026