Lilly Zyprexa 10mg Injection Recall: Cgmp Deviations in Drug Product
Lilly recalls Zyprexa 10mg injection vials due to cGMP deviations affecting drug appearance, size, and color. Affected vials may have safety concerns.
Lower-risk recall
cGMP deviations: Atypical appearance, decrease in size and change in color of the lyophilized cake of drug product.
Contact the company
What happened, in plain English
Lilly is recalling Zyp: 10mg injection vials because the drug product showed unusual changes in appearance, size, and color during manufacturing. This could potentially affect the safety and effectiveness of the medication. Read more at govinfonow.com/recall/36106-lilly-zyprexa-10mg-injection-recall-cgmp-deviations-in-drug-product.
Source Summary by GovInfoNow · govinfonow.com/recall/36106-lilly-zyprexa-10mg-injection-recall-cgmp-deviations-in-drug-product · Updated August 18, 2026 · FDA enforcement record: FDA #D-0720-2021
Cite this page
“Lilly Zyprexa 10mg Injection Recall: Cgmp Deviations in Drug Product.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/36106-lilly-zyprexa-10mg-injection-recall-cgmp-deviations-in-drug-product. Based on FDA recall #D-0720-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0720-2021%22&limit=1).
Why it’s dangerous
The drug product showed atypical changes in appearance, size, and color during manufacturing. These deviations may indicate issues with the medication's quality or safety, though the exact risk level is not specified in the recall.
Who’s affected
People prescribed Zyprexa injections by a doctor who received the specific vial lot number 197 from Lilly USA. Those with a prescription for this medication are most at risk.
How to tell if you have this one
Check for the vial label with 'Zyprexa Intramuscular, Olanzapine for Injection, 10 MG per Single Use Vial, Rx only'. The specific lot number 197 is affected.
- Brand
Lilly- Category
Drug
What to do — step by step
Check Vial Details
Look for the lot number 197 on the vial label to confirm if it's affected.
Where it went and when
Where it was distributed
Distributed in 3 states.
FDA distribution: “OH, MS, IN” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Indiana, Mississippi, Ohio.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0720-2021 (June 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0720-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.