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FDA · Drugs ·

Olanzapine Tablets recall

Macleods Pharmaceuticals Limited recalled Olanzapine Tablets on September 30, 2026 because of failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification. It was sold nationwide.

Why it was recalled

Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.

What's recalled

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.

Quantity: 22,032 30-count bottles

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
Macleods Pharmaceuticals Limited, Tehsil Baddi, District Solan
Date
Severity
Class III
the product is unlikely to cause health problems but breaks a rule.
Where sold
Nationwide
Nationwide in the USA
Status
Ongoing
Recall number
D-0867-2026
Source
U.S. Food and Drug Administration

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