Olanzapine recalls

Olanzapine products have been recalled 4 times, most recently on 30 Sep 2026. The recalling company is usually Macleods Pharmaceuticals. The most common reason is potency & assay.

Total recalls4since 2017

Last 12 months1reported

Class I00% of total

Ongoing2latest 30 Sep 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 1 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 1 0

Severity split

Class I 0 0%Class II 2 50%Class III 2 50%

Why olanzapine is recalled

Potency & Assay375%
Manufacturing (CGMP) Deviations125%

Companies

By year

2026125%
2024125%
2022125%
2017125%

Ongoing olanzapine recalls

2 active

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Drug	CLASS III	Olanzapine Tablets, USP 5 mg recalled by Macleods PharmaceuticalsOlanzapine	Macleods Pharmaceuticals	Potency & Assay	Nationwide
25 Dec 2024Drug	CLASS II	Olanzapine Tablets, USP 2.5 mg recalled by Macleods PharmaceuticalsOlanzapine	Macleods Pharmaceuticals	Potency & Assay	Nationwide

All olanzapine recalls, newest first

4 total

Reported	Class	Recall	Company	Reason	Where
30 Sep 2026Drug	CLASS III	Olanzapine Tablets, USP 5 mg recalled by Macleods PharmaceuticalsOlanzapine	Macleods Pharmaceuticals	Potency & Assay	Nationwide
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
15 Feb 2017Drug	CLASS III	Olanzapine tablets, USP, 2.5 mg recalled by Dr. Reddy's LaboratoriesOlanzapine	Dr. Reddy's Laboratories	Potency & Assay	Nationwide

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.