CLASS II Drug recall · Reported 18 Aug 2021 · FDA Enforcement Report
Zyprexa Intramuscular, Olanzapine for Injection recalled by Eli Lilly &
Eli Lilly is recalling Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, distributed in Indiana, Mississippi, Ohio. The recall was initiated on 29 Jun 2021 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-0720-2021
- FDA event ID
- 88193
- Recalling firm
- Eli Lilly, Indianapolis, IN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2021
- FDA classified
- 11 Aug 2021
- Reported
- 18 Aug 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Injectable & IV Drugs
Timeline
| 29 Jun 2021 | Recall initiated by company | |
| 11 Aug 2021 | Classified by FDA | +43 days |
| 18 Aug 2021 | 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: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Product as listed by the FDA
Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only, Marketed by: Lilly USA, LLC, Indianapolis, IN 46285, NDC# 0002-7597-01
Where it was distributed
OH, MS, IN
Questions about this recall
Why was it recalled?
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Which lots are affected?
Lot # 197
Where was it sold?
OH, MS, IN
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 26 Sep 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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