FDAClass IIDecember 25, 2024

Olanzapine Tablets recall: Impurity Out of Spec

Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods…

Why was Olanzapine Tablets recalled?

Failed Impurities/Degradation Specifications

What should I do if I have this product?

The recall is ongoing. Follow the firm and FDA instructions.

What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.

Is my product affected?

Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.

Which lot codes, UPCs or models are affected?

Lot# BOB12318A Exp 07/31/2027

Product
Olanzapine Tablets, USP 2.5 mg, 30-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured for: Macleods…
Recalling firm
Macleods Pharmaceuticals Ltd
Quantity
15,744 30-count bottles
Distribution
Nationwide in the USA
Recall date
December 25, 2024
Classification
Class II
Status
Ongoing
Agency
FDA (drug)
Open FDA enforcement record Latest recalls