Eli Lilly Recalls Humalog Sterile Diluent Due to Manufacturing Deviations
Eli Lilly & Company has voluntarily recalled 700 vials of Humalog sterile diluent due to Current Good Manufacturing Practice (CGMP) deviations. The affected batch (D608951C, exp. 4/10/2025) was distributed nationwide.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This FDA Class II recall cites Current Good Manufacturing Practice (CGMP) deviations affecting a sterile injectable product. Although no illnesses, injuries, or hospitalizations have been reported, manufacturing deviations for a sterile diluent represent a risk-of-harm situation without yet-reported injury, consistent with the rubric's criteria for Score 3.
Plain-English summary
Eli Lilly & Company has voluntarily recalled 700 vials of HUMALOG sterile diluent (Insulin Lispro Injection) due to identified Current Good Manufacturing Practice (CGMP) deviations. The sterile diluent is a 10 mL product intended for use only with insulin formulations specified on the carton. The affected batch number is D608951C, expiring April 10, 2025.
The product was distributed nationwide throughout the United States. The firm initiated the recall on March 12, 2024, following identification of the manufacturing deviations. The U.S. Food and Drug Administration has classified this action as a Class II recall.
Individuals, healthcare providers, and pharmacists with vials from batch D608951C should verify the batch number and expiration date on their product. Questions about the recall should be directed to Eli Lilly & Company or a healthcare provider.
The recalled product
- Product
- HUMALOG (INSULIN LISPRO)
- Brand
- HUMALOG
- Manufacturer
- Eli Lilly & Company
- Category
- Drug — Injectables
- Hazard
- cgmp-deviation
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Batch number: D608951C
- exp 4/10/2025
Distribution
Distributed nationwide across the United States.
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