Pitavastatin recalls

The FDA has published 7 recalls involving Pitavastatin since 2021. The latest was reported on 25 Mar 2026. Most were for potency & assay. AvKARE 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 recalls7since 2021

Last 12 months1reported

Class I00% of total

Ongoing5latest 25 Mar 2026

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 0Jan '25 0 1 0Apr 0 0 4Jul 0 0 0Oct 0 0 0Jan '26 0 1 0Apr 0 0 0Jul 0 0

Severity split

Class I 0 0%Class II 1 14%Class III 6 86%

Why pitavastatin is recalled

Companies

AvKARE229%
Orient Pharma Co., Ltd. Yunlin Plant229%
Annora Pharma Private114%
Cardinal Health114%
Kowa Pharmaceuticals America114%

Brands

By year

2026114%
2025571%
2021114%

Ongoing pitavastatin recalls

5 active

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Drug	CLASS III	Pitavastatin Tablets, 2 mg recalled by Annora Pharma PrivatePitavastatin Calcium	Annora Pharma Private	Packaging Defects	TN
9 Jul 2025Drug	CLASS III	Pitavastatin Tablets, 2 mg recalled by Orient Pharma Co., Ltd.Pitavastatin	Orient Pharma Co., Ltd. Yunlin Plant	Potency & Assay	NJ
9 Jul 2025Drug	CLASS III	Pitavastatin Tablets, 2 mg recalled by AvKAREPitavastatin	AvKARE	Potency & Assay	Nationwide
9 Jul 2025Drug	CLASS III	Pitavastatin Tablets, 1 mg recalled by Orient Pharma Co., Ltd.Pitavastatin	Orient Pharma Co., Ltd. Yunlin Plant	Potency & Assay	NJ
9 Jul 2025Drug	CLASS III	Pitavastatin Tablets, 1 mg recalled by AvKAREPitavastatin	AvKARE	Potency & Assay	Nationwide

All pitavastatin recalls, newest first

7 total

Reported	Class	Recall	Company	Reason	Where
25 Mar 2026Drug	CLASS III	Pitavastatin Tablets, 2 mg recalled by Annora Pharma PrivatePitavastatin Calcium	Annora Pharma Private	Packaging Defects	TN
9 Jul 2025Drug	CLASS III	Pitavastatin Tablets, 2 mg recalled by Orient Pharma Co., Ltd.Pitavastatin	Orient Pharma Co., Ltd. Yunlin Plant	Potency & Assay	NJ
9 Jul 2025Drug	CLASS III	Pitavastatin Tablets, 2 mg recalled by AvKAREPitavastatin	AvKARE	Potency & Assay	Nationwide
9 Jul 2025Drug	CLASS III	Pitavastatin Tablets, 1 mg recalled by Orient Pharma Co., Ltd.Pitavastatin	Orient Pharma Co., Ltd. Yunlin Plant	Potency & Assay	NJ
9 Jul 2025Drug	CLASS III	Pitavastatin Tablets, 1 mg recalled by AvKAREPitavastatin	AvKARE	Potency & Assay	Nationwide
19 Mar 2025Drug	CLASS III	Livalo (pitavatstatin) tablets, 4 mg recalledLivalo	Kowa Pharmaceuticals America	Other	OH, PA, TX
2 Jun 2021Drug	CLASS II	Livalo (pitavastatin) tablets 2 mg* recalled by Cardinal HealthLivalo	Cardinal Health	Manufacturing (CGMP) Deviations	FL, GA, SC

Should you stop taking Pitavastatin?

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.