FDA-Drug2026-09-30Class IIICHEMICAL
Macleods Olanzapine 5 mg tablets recalled for elevated impurities
What this means
Macleods Pharmaceuticals has recalled Olanzapine Tablets USP 5 mg (lot BOB22321A, expiring 07-31-2027) because testing found organic impurities above acceptable limits. The affected bottles were distributed nationwide. No injuries have been reported.
- Check if you have this medication by looking for lot number BOB22321A on the label.
- Contact your pharmacist or doctor if you have affected bottles — do not stop taking your medication without guidance.
- Your pharmacy can verify whether your supply is affected and provide replacement or alternative medication if needed.
The agency's original wording
Hazard
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
22,032 30-count bottles
Manufactured in
Village Theda, Post Office Lodhimajra, Tehsil Baddi, District Solan, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0867-2026Want us to check the next one for you?
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