Recall D-0867-2026

US Class III Ongoing · initiated 2026-08-27

Recalling firm

Macleods Pharmaceuticals Limited

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.

Reason for recall

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

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