Paroxetine recalls

The FDA has published 16 recalls involving Paroxetine since 2014. The latest was reported on 6 Dec 2023. Most were for potency & assay. Apotex 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 recalls16since 2014

Last 12 months0reported

Class I00% of total

Ongoing4latest 6 Dec 2023

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 0 0%Class II 15 94%Class III 1 6%

Why paroxetine is recalled

Companies

Brands

By year

2023744%
2017425%
2014531%

Ongoing paroxetine recalls

4 active

Reported	Class	Recall	Company	Reason	Where
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine	Apotex	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine	Apotex	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine	Apotex	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine	Apotex	Potency & Assay	Nationwide

All paroxetine recalls, newest first

16 total

Reported	Class	Recall	Company	Reason	Where
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine	Apotex	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine tablets, USP, 20 mg, Packaged as a) recalledParoxetine	Golden State Medical Supply	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine	Apotex	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine tablets, USP, 40 mg, Packaged as a) recalledParoxetine	Golden State Medical Supply	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine	Apotex	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine tablets, USP, 10 mg, Packaged as a) recalledParoxetine	Golden State Medical Supply	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by ApotexParoxetine	Apotex	Potency & Assay	Nationwide
6 Dec 2017Drug	CLASS II	Paroxetine Tablets USP, 30 mg, a) recalled by Zydus Pharmaceuticals USAParoxetine	Zydus Pharmaceuticals USA	Other	Nationwide
29 Nov 2017Drug	CLASS II	Paroxetine Tablets, USP, 30mg (10 x recalledParoxetine	Amerisource Health Services	Packaging Defects	Nationwide
20 Sep 2017Drug	CLASS II	Paroxetine tablets USP, 30mg recalled by Zydus Pharmaceuticals USAParoxetine	Zydus Pharmaceuticals USA	Other	Nationwide

Should you stop taking Paroxetine?

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.