Olanzapine recalls

Olanzapine products have been recalled 3 times, most recently on 25 Dec 2024. The recalling company is usually Macleods Pharma Usa. The most common reason is potency & assay.

Total recalls3since 2017

Last 12 months0reported

Class I00% of total

Ongoing1latest 25 Dec 2024

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 1 0Jan '25 0 0 0Apr 0 0 0Jul 0 0 0Oct 0 0 0Jan '26 0 0 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 2 67%Class III 1 33%

Why olanzapine is recalled

Potency & Assay267%
Manufacturing (CGMP) Deviations133%

Companies

By year

2024133%
2022133%
2017133%

Ongoing olanzapine recalls

1 active

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

All olanzapine recalls, newest first

3 total

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
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, 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.