⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Macleods Pharmaceuticals Limited: Olanzapine Tablets, USP 5 mg, 30-count bottle, Rx Only, Manufactured For: Macleods Pharma USA, Inc. Princeton, NJ, 08540; Manufactured by: M

DrugsSource: FDA (drug) · Date: 2026-09-30

Read the official notice at FDA (drug) →

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
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 / hazard
Failed Impurities/Degradation Specifications:Organic and unspecified impurities above specification.
Classification
Class III
Status
Ongoing
Distribution / sold at
Nationwide in the USA
Recall initiated
2026-08-27
Code info
Lot: BOB22321A, Exp 07-31-2027.
Product quantity
22,032 30-count bottles
Voluntary mandated
Voluntary: Firm initiated
City
Tehsil Baddi, District Solan
Country
India
Event id
99773
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