Official recall notice

FDA DrugClass IIINotable

Olanzapine Tablets Recall (Sep 2026)

Product: 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.

Recall date
2026-09-30
Category
Drug
FDA class
Class III

Why it was recalled

Hazard

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

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Product description

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

Affected products

Lot: BOB22321A, Exp 07-31-2027.

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