Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only,… was recalled on August 27, 2026 in cooperation with the U.S. Food and Drug Administration because failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification..
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: BOB22321A, Exp 07-31-2027.
Units affected: 22,032 30-count bottles
Where it was sold: Nationwide in the USA
Compare the codes above against the label on your product — usually on the bottom, the back panel, or the packaging. If your unit isn't listed, it is not part of this recall.
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Class III means the product is unlikely to cause a health problem, but it violates FDA labeling or manufacturing rules.
Stop using the product. Return it to the place of purchase for a refund, or dispose of it. Contact the recalling firm with questions.
Contact: Recalling firm: Macleods Pharmaceuticals Limited
Not sure what you're entitled to? Read our guide: what to do if your product is recalled.
Always confirm details on the official notice from the U.S. Food and Drug Administration before acting.
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Failed dissolution specifications.
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