Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07.
Published September 30, 2026 · Recall initiated: August 27, 2026
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- OLANZAPINE
- Manufacturer
- Macleods Pharmaceuticals Limited
- Distributor
- Nationwide in the USA
- UPC
- 0333342067074
- Lot
- Lot: BOB22321A, Exp 07-31-2027.
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- India
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Questions about this recall
Was Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pradesh, INDIA, NDC 33342-068-07. recalled?
Yes. FDA published recall D-0867-2026 on September 30, 2026. Reported hazard: Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
What should I do if I have this product?
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
How do I know if my unit is part of the recall?
Compare your product details with the notice. Brand: OLANZAPINE. UPC: 0333342067074.
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