Olanzapine Tablets 5 mg Recall: Impurity Out of Spec
Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods…
Why was Olanzapine Tablets 5 mg recalled?
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
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: BOB22321A, Exp 07-31-2027.
- Product
- Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods…
- Recalling firm
- Macleods Pharmaceuticals Limited
- Quantity
- 22,032 30-count bottles
- Distribution
- Nationwide in the USA
- Recall started
- August 27, 2026
- Report date
- September 30, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)