Paroxetine recalls

Paroxetine products have been recalled 11 times, most recently on 6 Dec 2023. The recalling company is usually Apotex. The most common reason is potency & assay.

Total recalls11since 2017

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 10 91%Class III 1 9%

Why paroxetine is recalled

Companies

Product types

Antidepressants11100%

By year

2023764%
2017436%

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

11 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

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.