Class IIIDrug
Olanzapine Tablets recall
Summary
Macleods Pharmaceuticals Limited is recalling Olanzapine Tablets (drug). According to the FDA report, the reason is: Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. The FDA rated this a Class III: the product is unlikely to cause health problems but violates fda rules (e.g. labeling). Recall status: Ongoing.
Details from the FDA report
- Product
- 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.
- Reason
- Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
- Lot / code info
- Lot: BOB22321A, Exp 07-31-2027.
- Quantity
- 22,032 30-count bottles
- Distribution
- Nationwide in the USA
- Recalling company
- Macleods Pharmaceuticals Limited, Tehsil Baddi, District Solan, India
- Recall started
- August 27, 2026
- FDA report date
- September 30, 2026
- Classification
- Class III: The product is unlikely to cause health problems but violates FDA rules (e.g. labeling).
- Voluntary / mandated
- Voluntary: Firm initiated
- Status
- Ongoing
- Recall number
- D-0867-2026
What to do
- Check whether you have this product, and compare the lot numbers, codes, or dates on your package with the codes listed above.
- If it matches, stop using it and keep it away from children and pets.
- Contact the recalling company (Macleods Pharmaceuticals Limited) or the store where you bought it about returns or refunds.
- Do not stop a prescribed medication without first talking to your pharmacist or doctor; they can help find a safe replacement.
- If you think the product made you or someone else sick, contact a doctor or pharmacist. In an emergency call 911.
- You can report problems to the FDA via MedWatch.