CLASS II Drug recall · Reported 9 Mar 2022 · FDA Enforcement Report

Olanzapine Tablets, USP 10 mg recalled by Macleods Pharma Usa

Macleods Pharma Usa is recalling Olanzapine Tablets, USP 10 mg, distributed nationwide in the US. The recall was initiated on 16 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: BOB42029A, BOB4202B, Exp. Date 09/2022

NDC33342-067, 33342-068, 33342-069, 33342-070, 33342-071, 33342-072

UPC0333342067074, 0333342070074, 0333342069078, 0333342072078, 0333342071071, 0333342068071

Quantity recalled3672 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0639-2022
FDA event ID: 89607
Recalling firm: Macleods Pharma Usa, Plainsboro, NJ
Brand: Olanzapine
Manufacturer: Macleods Pharmaceuticals Limited
Classification: Class II
Status: Terminated
Recall initiated: 16 Feb 2022
FDA classified: 28 Feb 2022
Reported: 9 Mar 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Manufacturing (CGMP) Deviations

Timeline

16 Feb 2022	Recall initiated by company
28 Feb 2022	Classified by FDA	+12 days
9 Mar 2022	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

cGmp Deviations

Product as listed by the FDA

Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-07.

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Is Olanzapine Tablets, USP 10 mg recalled?

Yes. Macleods Pharma Usa recalled Olanzapine Tablets, USP 10 mg on 16 Feb 2022. The recall is Class II and its status is Terminated. Recall number D-0639-2022.

Why was it recalled?

cGmp Deviations

Which lots are affected?

Lot #: BOB42029A, BOB4202B, Exp. Date 09/2022

Where was it sold?

Nationwide within the United States

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Macleods Pharma Usa

All 34

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1 Apr 2026Drug	CLASS II	Levothyroxine Sodium Tablets USP 150 mcg recalled by Macleods Pharma UsaLevothyroxine Sodium	Macleods Pharma Usa	Potency & Assay	Nationwide
22 May 2024Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Foreign Material	Nationwide
25 Jan 2023Drug	CLASS III	Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa	Macleods Pharma Usa	Packaging Defects	Nationwide
13 Jul 2022Drug	CLASS II	Eszopiclone Tablets, USP 1 mg recalled by Macleods Pharma UsaEszopiclone	Macleods Pharma Usa	Packaging Defects	Nationwide
6 Jul 2022Drug	CLASS II	Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide

Other Olanzapine recalls

All 14

Reported	Class	Recall	Company	Reason	Where
25 Dec 2024Drug	CLASS II	Olanzapine Tablets, USP 5 mg recalled by Macleods PharmaceuticalsOlanzapine	Macleods Pharmaceuticals	Potency & Assay	Nationwide
15 Jun 2022Drug	CLASS II	Olanzapine Orally Disintegrating Tablets recalled	Mckesson Medical-Surgical Inc. Corporate Office	Manufacturing (CGMP) Deviations	Nationwide
11 Nov 2020Drug	CLASS III	Olanzapine Orally Disintegrating Tablets, 5 mg ( unit dose) recalled	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
24 Jun 2020Drug	CLASS III	Olanzapine Tablets, USP 5 mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Potency & Assay	Nationwide
24 Jun 2020Drug	CLASS III	Olanzapine Tablets, USP 5 mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Potency & Assay	Nationwide