Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540
Summary
The FDA issued a Class III for Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleo by Macleods Pharmaceuticals Limited. Reason: Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification..
Details
Source
Drug Recall
External ID
D-0867-2026
Action Date
2026-09-30
Status
Ongoing
Category
drug
Product Description
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.
Lot/Code Info: Lot: BOB22321A, Exp 07-31-2027.
Quantity Affected: 22,032 30-count bottles
Reason for Recall
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-08-27
Company
Tehsil Baddi, District Solan
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 26 drug recalls issued in the same week, part of 66 drug-related FDA actions this month.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Macleods Pharmaceuticals Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Macleods Pharmaceuticals Limited have FDA actions?
This is the only FDA action we have on record for Macleods Pharmaceuticals Limited in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0867-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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