Paliperidone recalls

The FDA has published 5 recalls involving Paliperidone since 2016. The latest was reported on 16 Mar 2022. Most were for potency & assay. Teva Pharmaceuticals U 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 recalls5since 2016

Last 12 months0reported

Class I120% of total

Ongoing0latest 16 Mar 2022

Recalls per month, last 24 months

click a bar for that month

0Oct '24 0 0 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 1 20%Class II 4 80%Class III 0 0%

Why paliperidone is recalled

Potency & Assay360%
Packaging Defects240%

Companies

By year

2022120%
2018240%
2017120%
2016120%

All paliperidone recalls, newest first

5 total

Reported	Class	Recall	Company	Reason	Where
16 Mar 2022Drug	CLASS II	Paliperidone Extended-release Tablets, 9 mg per carton recalledPaliperidone	The Harvard Drug Group	Potency & Assay	Nationwide
31 Oct 2018Drug	CLASS II	Paliperidone Extended Release Tablets 3 mg recalled	Teva Pharmaceuticals U	Packaging Defects	Nationwide
31 Oct 2018Drug	CLASS II	Paliperidone Extended Release Tablets 9 mg recalled	Teva Pharmaceuticals U	Packaging Defects	Nationwide
19 Jul 2017Drug	CLASS I	Paliperidone Extended-Release Tablets, 3 mg recalled	Teva Pharmaceuticals	Potency & Assay	Nationwide
18 May 2016Drug	CLASS II	Paliperidone Extended-release Tablets, 5 mg recalled	Mylan Pharmaceuticals	Potency & Assay	Nationwide

Should you stop taking Paliperidone?

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.