Eli Lilly & Company

Complete recall history across all FDA and CPSC categories — 4 total recalls

Eli Lilly & Company appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.

Drug Recalls (4)

FDA drug safety enforcement actions by Eli Lilly & Company

Date Product Reason Class
Mar 12, 2024 Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 RE... CGMP Deviations Class II
Sep 24, 2021 Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per ... SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected po... Class I
Aug 19, 2021 Trulicity (dulaglutide), 0.75 mg/0.5 mL, 4 Single-Dose Pens per box, Rx only,... Labeling: Label error on declared strength - autoinjector devices labeled as ... Class II
Jun 29, 2021 Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, R... cGMP deviations: Atypical appearance, decrease in size and change in color of... Class II

Frequently Asked Questions

A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.

Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.

The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.

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