Eli Lilly & Sterile Diluent Recall: FDA Class II

Why it was recalled

CGMP Deviations

Product description

Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01

Lot numbers, UPCs & expiration codes

Batch number: D608951C, exp 4/10/2025

Where it was sold

Nationwide USA

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0445-2024
Classification: Class II
Status: Completed
Recall initiated: Mar 12, 2024
FDA report date: Apr 24, 2024
Quantity: 700 vials
Recall type: Voluntary: Firm initiated
Recalling firm: Eli Lilly & Company

Original FDA data

Every field from FDA enforcement report D-0445-2024, exactly as published.

Show all FDA fields

City: Indianapolis
State: IN
Status: Completed
Country: United States
Event ID: 94214
Address: 893 S Delaware St
Code information: Batch number: D608951C, exp 4/10/2025
Postal code: 46225-1782
Report date: Apr 24, 2024
Product type: Drugs
Recall number: D-0445-2024
Classification: Class II
Recalling firm: Eli Lilly & Company
Product quantity: 700 vials
Reason for recall: CGMP Deviations
Voluntary / mandated: Voluntary: Firm initiated
Product description: Sterile Diluent, HUMALOG U-100 (insulin lispro injection), HUMULIN R U-100 REGULAR (insulin human injection), Insulin Lispro Injection u-100, 10 mL, Use ONLY with Insulins listed on carton, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285. NDC: 0002-0800-01
Distribution pattern: Nationwide USA
Recall initiation date: Mar 12, 2024
Initial firm notification: E-Mail
Center classification date: Apr 17, 2024

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0445-2024, published Apr 24, 2024. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

Eli Lilly & Sterile Diluent Recall

Summary