CLASS II Drug recall · Reported 24 Apr 2024 · FDA Enforcement Report
Sterile Diluent, Humalog U-100 (insulin lispro injection) recalled
Eli Lilly is recalling Sterile Diluent, Humalog U-100 (insulin lispro injection), Humulin R U-100 Regular, distributed nationwide in the US. The recall was initiated on 12 Mar 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0445-2024
- FDA event ID
- 94214
- Recalling firm
- Eli Lilly, Indianapolis, IN
- Brand
- Humalog
- Manufacturer
- Eli Lilly and Company
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 12 Mar 2024
- FDA classified
- 17 Apr 2024
- Reported
- 24 Apr 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Diabetes Medication
Timeline
| 12 Mar 2024 | Recall initiated by company | |
| 17 Apr 2024 | Classified by FDA | +36 days |
| 24 Apr 2024 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
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
Where it was distributed
Nationwide USA
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
Batch number: D608951C, exp 4/10/2025
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 9 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS I | Glucagon Emergency Kit for Low Blood Sugar, Glucagon recalled | Eli Lilly | Potency & Assay | Nationwide |
| Drug | CLASS II | Trulicity (dulaglutide), 0.75 mg/-Dose Pens recalled by Eli Lilly &Trulicity | Eli Lilly | Other | Nationwide |
| Drug | CLASS II | Zyprexa Intramuscular, Olanzapine for Injection recalled by Eli Lilly & | Eli Lilly | Manufacturing (CGMP) Deviations | IN, MS, OH |
| Drug | CLASS III | Erbitux Cetuximab Injection, 200 mg/ (2 mg/mL) per single-use vial recalledErbitux | Eli Lilly | Labeling Errors | 11 states |
Other Insulin Lispro recalls
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Admelog, insulin lispro injection/mL (U-100) multi-dose vial recalledAdmelog | Sanofi-Aventis U.S | Sterility | Nationwide |
| Drug | CLASS I | Humalog KwikPen, Insulin lispro injection, U-100 per mL recalledHumalog | Cardinal Health | Temperature Abuse | NM |
| Drug | CLASS II | Admelog Solostar (insulin lispro injection)/ mL (U-100) injection recalledAdmelog | Sanofi-Aventis U.S | Temperature Abuse | Nationwide |