Olanzapine 2.5 mg Tablets Recalled for Failed Impurity Specifications
Macleods Pharmaceuticals is recalling Olanzapine 2.5 mg tablets nationwide due to failed impurities and degradation specifications. The recall affects one production lot distributed across the United States.
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 with no reported illnesses or injuries. The recall addresses quality control issues (failed impurities and degradation specifications) in a precautionary manner, without documented harm to patients.
Plain-English summary
Macleods Pharmaceuticals Ltd is recalling Olanzapine (olanzapine) 2.5 mg tablets in 30-count bottles due to failed impurities and degradation specifications that do not meet established pharmaceutical standards.
The recall affects 15,744 bottles with lot number BOB12318A (expiration 07/31/2027), distributed nationwide throughout the United States. The product carries NDC 33342-067-07 and is manufactured by Macleods Pharmaceuticals Ltd in Baddi, Himachal Pradesh, India, for Macleods Pharma USA, Inc. in Princeton, New Jersey.
Patients currently taking this medication should contact their pharmacy or healthcare provider to determine whether their prescription is affected. Do not stop taking olanzapine without medical guidance, as discontinuing this medication without supervision could affect your psychiatric treatment. Your healthcare provider can confirm lot number eligibility and advise on next steps.
The recalled product
- Product
- OLANZAPINE (OLANZAPINE)
- Brand
- OLANZAPINE
- Manufacturer
- Macleods Pharmaceuticals Ltd
- Category
- Drug — Psychiatric Medication
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# BOB12318A Exp 07/31/2027
UPCs (6)
- 0333342067074
- 0333342070074
- 0333342069078
- 0333342072078
- 0333342071071
- 0333342068071
Distribution
Distributed nationwide across the United States.
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