Olanzapine recalls
The FDA has published 16 recalls involving Olanzapine since 2013. The latest was reported on 30 Sep 2026. Most were for potency & assay. Sun Pharmaceutical Industries has the most recalls in this group. Recalls usually affect specific lots, not every bottle on the market. Check the lot number on each recall page before acting.
Total recalls 16 since 2013
Last 12 months 1 reported
Class I 0 0% of total
Ongoing 2 latest 30 Sep 2026
Recalls per month, last 24 months click a bar for that month Severity split
0 0%5 31%11 69%
Why olanzapine is recalled
Ongoing olanzapine recalls 2 active
All olanzapine recalls, newest first 16 total Reported Class Recall Company Reason Where 30 Sep 2026 Drug CLASS III Olanzapine Tablets, USP 5 mg recalled by Macleods Pharmaceuticals Olanzapine Macleods Pharmaceuticals Potency & Assay Nationwide 25 Dec 2024 Drug CLASS II Olanzapine Tablets, USP 2.5 mg recalled by Macleods Pharmaceuticals Olanzapine Macleods Pharmaceuticals Potency & Assay Nationwide 9 Mar 2022 Drug CLASS II Olanzapine Tablets, USP 10 mg recalled by Macleods Pharma Usa Olanzapine Macleods Pharma Usa Manufacturing (CGMP) Deviations Nationwide 24 Jun 2020 Drug CLASS III Olanzapine Tablets, USP 2.5 mg recalled by Aurobindo Pharma USA Aurobindo Pharma USA Potency & Assay Nationwide 24 Jun 2020 Drug CLASS III Olanzapine Tablets, USP 7.5 mg recalled by Aurobindo Pharma USA Aurobindo Pharma USA Potency & Assay Nationwide 17 May 2017 Drug CLASS III Olanzapine Tablets, 20 mg recalled by Sun Pharmaceutical Industries Sun Pharmaceutical Industries Potency & Assay Nationwide 17 May 2017 Drug CLASS III Olanzapine Tablets, 10 mg recalled by Sun Pharmaceutical Industries Sun Pharmaceutical Industries Potency & Assay Nationwide 17 May 2017 Drug CLASS III Olanzapine Tablets, 2.5 mg recalled by Sun Pharmaceutical Industries Sun Pharmaceutical Industries Potency & Assay Nationwide 17 May 2017 Drug CLASS III Olanzapine Tablets, 7.5 mg recalled by Sun Pharmaceutical Industries Sun Pharmaceutical Industries Potency & Assay Nationwide 15 Feb 2017 Drug CLASS III Olanzapine tablets, USP, 2.5 mg recalled by Dr. Reddy's Laboratories Olanzapine Dr. Reddy's Laboratories Potency & Assay Nationwide 20 May 2015 Drug CLASS III Olanzapine, Orally Disintegrating Tablets, 5 mg, a) bottle recalled Apotex Potency & Assay Nationwide 20 May 2015 Drug CLASS III Olanzapine, Orally Disintegrating Tablets, 10 mg, a) bottle recalled Apotex Potency & Assay Nationwide 20 May 2015 Drug CLASS III Olanzapine, Orally Disintegrating Tablets, 20 mg recalled by Apotex Apotex Potency & Assay Nationwide 22 Jan 2014 Drug CLASS II OLANZapine Tablet, 7.5 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 22 Jan 2014 Drug CLASS II Olanzapine, Tablet 7.5 mg recalled by Aidapak Services Aidapak Services Labeling Errors 4 states 7 Aug 2013 Drug CLASS II Olanzapine Tablets, USP, 10 mg recalled by Torrent Pharma Torrent Pharma Packaging Defects Nationwide
Should you stop taking Olanzapine?
Not on your own. Most recalls affect specific lots from one manufacturer, and stopping a prescription suddenly can be riskier than the defect. Check your lot number and NDC against the recall, then call the pharmacy that dispensed it for a replacement.