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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Sterile Diluent for Humalog and Humulin Insulin Recalled for CGMP Deviations

Agency Publication Date: April 17, 2024
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Summary

Eli Lilly & Company has recalled 700 vials of Sterile Diluent used with Humalog U-100 (insulin lispro), Humulin R U-100 (insulin human), and Insulin Lispro Injection U-100 (10 mL). The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, which are failures to meet required manufacturing standards. Consumers should check their 10 mL vials for batch number D608951C with an expiration date of April 10, 2025. If you have this affected batch, contact your healthcare provider or pharmacist to discuss alternative options or a replacement.

Risk

Deviations in manufacturing processes can lead to quality and safety concerns for sterile products. While no specific injuries have been reported, using a diluent that does not meet strict quality standards could potentially impact the effectiveness or safety of the insulin treatment.

What You Should Do

  1. This recall affects 10 mL vials of Eli Lilly Sterile Diluent used with Humalog U-100, Humulin R U-100, and Insulin Lispro Injection U-100. Affected products are labeled with NDC 0002-0800-01, batch number D608951C, and an expiration date of April 10, 2025.
  2. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  3. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Sterile Diluent (10 mL)
Variants: Used with HUMALOG U-100 (insulin lispro injection), Used with HUMULIN R U-100 REGULAR (insulin human injection), Used with Insulin Lispro Injection U-100
Lot Numbers:
D608951C (Exp 4/10/2025)
NDC:
0002-0800-01

Marketed by Lilly USA, LLC. Total of 700 vials affected.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94214
Status: Resolved
Manufacturer: Eli Lilly & Company
Sold By: Pharmacies; Hospitals; Healthcare Providers
Manufactured In: United States
Units Affected: 700 vials
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.