Olanzapine Tablets Recalled Due to Failed Impurities Specifications

Key Takeaways:

• The US Food and Drug Administration (FDA) has issued a voluntary Class III recall for olanzapine tablets, USP, 5 mg. The affected batch has been identified as Lot BOB22321A (expiring July 2027), containing 22 032 bottles.
• The recall was initiated by Macleods Pharmaceuticals, Ltd due to the product’s failure to meet impurities specifications, a quality issue that is not likely to cause adverse health consequences.
• Olanzapine tablets are used to treat schizophrenia, bipolar 1 disorder, and depression.

The FDA has issued a Class III recall for olanzapine tablets, USP, 5 mg, affecting 22 032 bottles. This product is being recalled by Macleods Pharmaceuticals, Ltd based in Tehsil Baddi, India. The recall was initiated on August 27, 2026, and received a Class III classification on September 22, 2026. A Class III classification means the use of this product is not likely to cause adverse health consequences.

The recall was initiated after the product failed to meet impurities specifications, with organic impurity levels being above regulation. This deficiency affects Lot BOB22321A, which will expire in July 2027. Macleods Pharmaceuticals has sent out public notices via email, fax, letter, telephone, or in-person visits; no press release has been issued for this recall.

Olanzapine is a prescription medication used to treat schizophrenia and bipolar 1 disorder. It can also be used to treat depression in patients for whom antidepressants have not worked well. Pharmacists should identify and quarantine Lot BOB22321A, remove it from inventory, and coordinate with prescribers to provide an alternative supply.

Reference

FDA. Enforcement Report. September 30, 2026. Accessed September 30, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=222447