Macleods Pharmaceuticals Limited — 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, Him

Official product recall notices and clearly labeled enforcement reference records.

Reference record — not a live warning · enforcement-reference · official-source

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

Provider: FDA — drug enforcement reference
Source observed: 9/30/2026, 12:00:00 AM UTC
Source updated: 9/30/2026, 12:00:00 AM UTC
Location: Tehsil Baddi, District Solan, US
hazard: Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
notice: Periodic enforcement reference; not a real-time safety alert or a reliable recall-lifecycle tracker.
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.
distribution: Nationwide in the USA
manufacturer: Macleods Pharmaceuticals Limited
recall number: D-0867-2026
source status: Ongoing
classification: Class III
freshness minutes: 180

Source use policy · openFDA reference data; not a real-time public alert service

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