Sterile Diluent recall
FDA recall D-0445-2024 · initiated Mar 12, 2024
Eli Lilly & Company recalled Sterile Diluent in Mar 2024 — an FDA Class II recall (D-0445-2024) because CGMP Deviations.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
CGMP Deviations
The manufacturing process itself
The FDA found the process itself out of compliance, usually before any defective product was identified.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 700 vials
Details
- Product
- 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
- Recalling company
- Eli Lilly Co
- Classification
- Class II
- Status
- Completed
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide USA
- Initiated
- Mar 12, 2024
- FDA report date
- Apr 24, 2024
This recall is linked to a product we cover: Humalog Tempo Pen →
Frequently asked
- Was Sterile Diluent recalled?
- Eli Lilly & Company recalled Sterile Diluent in Mar 2024 — an FDA Class II recall (D-0445-2024) because CGMP Deviations. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Sterile Diluent recalled?
- Per the FDA enforcement record, the reason for recall D-0445-2024 was: CGMP Deviations
- Is a recalled Sterile Diluent dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Sterile Diluent are affected?
- Distributed: Nationwide USA. The recall covers these lots — Batch number: D608951C, exp 4/10/2025. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0445-2024.