CLASS II Drug recall · Reported 6 Dec 2023 · FDA Enforcement Report

Paroxetine tablets, USP, 20 mg, Packaged as a) recalled

Golden State Medical Supply is recalling Paroxetine tablets, USP, 20 mg, Packaged as a), distributed nationwide in the US. The recall was initiated on 10 Nov 2023 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot # a) GS036696, GS037068, GS037934, GS038564, Exp. 08/31/2024 b) GS036381, GS036712, GS037116, GS037692, GS038388, Exp. 08/31/2024;

NDC60429-734, 60429-735, 60429-736, 60429-737

Quantity recalled2502 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0129-2024
FDA event ID: 93431
Recalling firm: Golden State Medical Supply, Camarillo, CA
Brand: Paroxetine
Manufacturer: Golden State Medical Supply, Inc.
Classification: Class II
Status: Terminated
Recall initiated: 10 Nov 2023
FDA classified: 30 Nov 2023
Reported: 6 Dec 2023
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Antidepressants

Timeline

10 Nov 2023	Recall initiated by company
30 Nov 2023	Classified by FDA	+20 days
6 Dec 2023	Published in enforcement report	+6 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.

Product as listed by the FDA

PAROXETINE tablets, USP, 20 mg, Packaged as a) 90-count bottle NDC 60429-735-90; b)1000-count bottle, NDC 60429-735-10; Rx Only, Manufactured by Apotex, Inc., Toronto, Ontario, Canada, M9L 1T9, Packaged by GSMS, Incorporated, Camarillo, CA 93012.

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Why was it recalled?

Failed Impurities/Degradation Specifications-Manufacturer Apotex Inc. recalling lots due to Out of specification results for the excipient Amadori Glucose adduct of Paroxetine

Which lots are affected?

Lot # a) GS036696, GS037068, GS037934, GS038564, Exp. 08/31/2024 b) GS036381, GS036712, GS037116, GS037692, GS038388, Exp. 08/31/2024;

Where was it sold?

Nationwide in the USA

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

2 other products · FDA event 93431

This product is part of a recall event; the main page for the event is Paroxetine tablets, USP, 10 mg, Packaged as a) recalled.

Reported	Class	Recall	Company	Reason	Where
6 Dec 2023	CLASS II	Paroxetine tablets, USP, 10 mg, Packaged as a) recalledParoxetine	Golden State Medical Supply	Potency & Assay	Nationwide
6 Dec 2023	CLASS II	Paroxetine tablets, USP, 40 mg, Packaged as a) recalledParoxetine	Golden State Medical Supply	Potency & Assay	Nationwide

More recalls from Golden State Medical Supply

All 55

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Prasugrel HCI, Tablets, USP, 10mg recalledPrasugrel	Golden State Medical Supply	Potency & Assay	Nationwide
26 Aug 2026Drug	CLASS II	Carbamazepine Tablets, USP, 200mg recalledCarbamazepine	Golden State Medical Supply	Manufacturing (CGMP) Deviations	Nationwide
17 Jun 2026Drug	CLASS II	Gsms Incorporated, Niacin Extended-release Tablets, USP, 1,000 MG recalledNiacin	Golden State Medical Supply	Potency & Assay	CA
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 250 mg recalled by Golden State Medical SupplyPrimidone	Golden State Medical Supply	Other	Nationwide
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 50 mg recalled by Golden State Medical SupplyPrimidone	Golden State Medical Supply	Other	Nationwide

Other Paroxetine recalls

All 15

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 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