CLASS III ONGOING Drug recall · Reported 30 Sep 2026 · FDA Enforcement Report

Olanzapine Tablets, USP 5 mg recalled by Macleods Pharmaceuticals

Macleods Pharmaceuticals is recalling Olanzapine Tablets, USP 5 mg, distributed nationwide in the US. The recall was initiated on 27 Aug 2026 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot: BOB22321A, Exp 07-31-2027.

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

UPC0333342067074, 0333342070074, 0333342069078, 0333342072078, 0333342071071, 0333342068071

Quantity recalled22,032 30-count 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-0867-2026
FDA event ID: 99773
Recalling firm: Macleods Pharmaceuticals, Tehsil Baddi, District Solan
Brand: Olanzapine
Manufacturer: Macleods Pharmaceuticals Limited
Classification: Class III
Status: Ongoing
Recall initiated: 27 Aug 2026
FDA classified: 22 Sep 2026
Reported: 30 Sep 2026
Type: Voluntary: Firm initiated
Customers notified by: Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Reason category: Potency & Assay

Timeline

27 Aug 2026	Recall initiated by company
22 Sep 2026	Classified by FDA	+26 days
30 Sep 2026	Published in enforcement report	+8 days

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

Reason for recall

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

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

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.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

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

Which lots are affected?

Lot: BOB22321A, Exp 07-31-2027.

Where was it sold?

Nationwide in the USA

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 III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 6 Oct 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 Pharmaceuticals

All 4

Reported	Class	Recall	Company	Reason	Where
16 Jul 2025Drug	CLASS III	Famciclovir Tablets, USP 500 mg recalled by Macleods PharmaceuticalsFamciclovir	Macleods Pharmaceuticals	Packaging Defects	Nationwide
18 Jun 2025Drug	CLASS III	Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg) recalledLevothyroxine Sodium	Macleods Pharmaceuticals	Other	Nationwide
25 Dec 2024Drug	CLASS II	Olanzapine Tablets, USP 2.5 mg recalled by Macleods PharmaceuticalsOlanzapine	Macleods Pharmaceuticals	Potency & Assay	Nationwide

Other Olanzapine recalls

All 16

Reported	Class	Recall	Company	Reason	Where
25 Dec 2024Drug	CLASS II	Olanzapine Tablets, USP 2.5 mg recalled by Macleods PharmaceuticalsOlanzapine	Macleods Pharmaceuticals	Potency & Assay	Nationwide
9 Mar 2022Drug	CLASS II	Olanzapine Tablets, USP 10 mg recalled by Macleods Pharma UsaOlanzapine	Macleods Pharma Usa	Manufacturing (CGMP) Deviations	Nationwide
24 Jun 2020Drug	CLASS III	Olanzapine Tablets, USP 2.5 mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Potency & Assay	Nationwide
24 Jun 2020Drug	CLASS III	Olanzapine Tablets, USP 7.5 mg recalled by Aurobindo Pharma USA	Aurobindo Pharma USA	Potency & Assay	Nationwide
17 May 2017Drug	CLASS III	Olanzapine Tablets, 20 mg recalled by Sun Pharmaceutical Industries	Sun Pharmaceutical Industries	Potency & Assay	Nationwide