Paroxetine recalls

The FDA has published 15 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 recalls15since 2014

Last 12 months0reported

Class I00% of total

Ongoing4latest 6 Dec 2023

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 14 93%Class III 1 7%

Why paroxetine is recalled

Companies

By year

2023747%
2017427%
2014427%

Ongoing paroxetine recalls

4 active

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

All paroxetine recalls, newest first

15 total

Reported	Class	Recall	Company	Reason	Where
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by Apotex	Apotex	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine tablets, USP, 20 mg, Packaged as a) recalled	Golden State Medical Supply	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by Apotex	Apotex	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine tablets, USP, 40 mg, Packaged as a) recalled	Golden State Medical Supply	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by Apotex	Apotex	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine tablets, USP, 10 mg, Packaged as a) recalled	Golden State Medical Supply	Potency & Assay	Nationwide
6 Dec 2023Drug	CLASS II	Paroxetine Hydrochloride Tablets recalled by Apotex	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 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
19 Jul 2017Drug	CLASS III	Paroxetine Extended-Release Tablets USP, 12.5 mg recalledParoxetine	Lupin Pharmaceuticals	Potency & Assay	Nationwide
10 Sep 2014Drug	CLASS II	Paroxetine HCL Controlled-Release Tablets 12.5 mg recalled by Apotex	Apotex	Other	Nationwide
10 Sep 2014Drug	CLASS II	Paroxetine HCL Controlled-Release Tablets 37.5 mg recalled by Apotex	Apotex	Other	Nationwide
10 Sep 2014Drug	CLASS II	Paroxetine HCL Controlled-Release Tablets 25 mg recalled by Apotex	Apotex	Other	Nationwide
22 Jan 2014Drug	CLASS II	PARoxetine HCl, Tablet, 10 mg recalled by Aidapak Services	Aidapak Services	Labeling Errors	4 states

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.