Macleods Olanzapine Tablets
Olanzapine Tablets, USP 5 mg, failed impurities and degradation specifications.
What happened
Macleods Pharmaceuticals Limited, based in Tehsil Baddi, District Solan, India, began a recall of Olanzapine Tablets, USP 5 mg, 30-count bottles, on August 27, 2026, because the product failed impurities and degradation specifications, with organic and unspecified impurities above specification. The tablets, manufactured for Macleods Pharma USA, Inc., Princeton, NJ, were distributed nationwide in the USA. The FDA added the recall to its Enforcement Report on September 22, 2026.
Summary by Recall Canary from the FDA notice.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
Olanzapine Tablets, USP 5 mg
- NDC
- 33342-068-07
- Lot
- BOB22321A
Details
- Company began the recall
- Sold in
Nationwide in the USA
- Event ID
- 99773
- Recall No.
- D-0867-2026
- Company
- Macleods Pharmaceuticals LimitedTehsil Baddi, District Solan, India
- Hazard
- Impurity or degradation
- Recall type
- Voluntary: Firm initiated
- Customers told by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
