Zyprexa Intramuscular Injection Recalled for Manufacturing Defects
Eli Lilly is recalling 36,540 vials of Zyprexa (olanzapine) 10 mg intramuscular injection due to manufacturing deviations affecting the drug product's appearance, size, and color.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving manufacturing deviations (cGMP violations) that affect product appearance and physical characteristics. The source text does not report any illnesses, injuries, or hospitalization; the hazard is the integrity concern from manufacturing deviation rather than a documented patient harm. Class II recalls with no reported adverse events typically fall in the Moderate range.
Plain-English summary
Eli Lilly & Company is recalling Zyprexa (olanzapine) for Injection, 10 mg per single-use vial (NDC# 0002-7597-01), Lot # 197. The recall was initiated due to current good manufacturing practice (cGMP) deviations identified in the lyophilized cake of the drug product.
The specific manufacturing deviations include atypical appearance, a decrease in size, and a change in color of the lyophilized cake. A total of 36,540 vials were affected by these deviations and have been distributed to Ohio, Mississippi, and Indiana.
Patients currently using this medication should contact their healthcare provider or pharmacist to determine whether their supply is affected and to discuss appropriate next steps. Healthcare providers should review patient records to identify affected doses and consult the manufacturer or FDA for guidance on patient management.
The recalled product
- Product
- 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
- Manufacturer
- Eli Lilly & Company
- Affected units
- 36,540
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 (1)
- Lot # 197
Distribution
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