Unrated Drug recall · FDA · Published March 12, 2024

Eli Lilly Recalls Insulin Products Due to Manufacturing Deviations

Eli Lilly recalls specific insulin products due to manufacturing deviations. Affected products include Humalog U-100 and Humulin R U-100 Regular. Consumers should check product labels for batch numbers and NDC codes.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0445-2024Drug Eli Lilly ›

Recall notice

CGMP Deviations

Take action

Contact the company

Recalling firmEli Lilly & Company893 S Delaware St · Indianapolis, IN 46225-1782

✎ GovInfoNow plain-language explainer

Eli Lilly has recalled certain insulin products, including Humalog U-100 and Humulin R U-100 Regular, because of manufacturing deviations. This recall affects people who use these insulins for diabetes management, as the products may not meet safety standards. Read more at govinfonow.com/recall/32778-eli-lilly-recalls-insulin-products-due-to-manufacturing-deviations.

Source Summary by GovInfoNow · govinfonow.com/recall/32778-eli-lilly-recalls-insulin-products-due-to-manufacturing-deviations · Updated August 17, 2026 · FDA enforcement record: FDA #D-0445-2024

Cite this page

“Eli Lilly Recalls Insulin Products Due to Manufacturing Deviations.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/32778-eli-lilly-recalls-insulin-products-due-to-manufacturing-deviations. Based on FDA recall #D-0445-2024 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0445-2024%22&limit=1).

Eli Lilly & Company voluntarily recalled Sterile Diluent and insulin products due to current good manufacturing practice deviations, the Food and Drug Administration said on March 12, 2024.

How to tell if you have it

Brand: Eli Lilly
Products: Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100
Size: 10 mL
NDC: 0002-0800-01
Batch number: D608951C
Expiration date: 4/10/2025
Quantity: 700 vials
Distribution: Nationwide USA

The hazard

The recall addresses current good manufacturing practice deviations, according to the FDA.

Context

GovInfoNow's records show Eli Lilly & Company has 3 other recalls on record since 2021-06-29. Other recent recalls of similar products include Baxter Healthcare's MYXREDLIN Insulin recall (2026-08-06), Wells Pharma's fentanyl injectable solution recall (2026-04-01), and Amgen's Sensipar 60mg tablets recall (2026-06-04).

How to tell if you have this one

Check the product label for the batch number D608951C and expiration date 4/10/2025. The NDC code 0002-0800-01 is also associated with this specific product.

Brand
Eli Lilly
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for the batch number D608951C and expiration date 4/10/2025 on the insulin product label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 43 days after the firm started it.

Mar 12, 2024Firm started the recall
Apr 17, 2024FDA classified it Class II
Apr 24, 2024Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/32778-eli-lilly-recalls-insulin-products-due-to-manufacturing-deviations">Eli Lilly Recalls Insulin Products Due to Manufacturing Deviations (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0445-2024 (March 12, 2024) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0445-2024 to see it in context.
Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.