CLASS II Drug recall · Reported 29 Nov 2017 · FDA Enforcement Report

Paroxetine Tablets, USP, 30mg (10 x recalled

Amerisource Health Services is recalling Paroxetine Tablets, USP, 30mg (10 x, distributed nationwide in the US. The recall was initiated on 24 Oct 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot 172291

NDC68084-044, 68084-045, 68084-046, 68084-047

Quantity recalled74 cartons (cartons of 100 individual unit doses)

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-0091-2018
FDA event ID: 78490
Recalling firm: Amerisource Health Services, Columbus, OH
Brand: Paroxetine
Manufacturer: American Health Packaging
Classification: Class II
Status: Terminated
Recall initiated: 24 Oct 2017
FDA classified: 21 Nov 2017
Reported: 29 Nov 2017
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects
Drug class: Antidepressants

Timeline

24 Oct 2017	Recall initiated by company
21 Nov 2017	Classified by FDA	+28 days
29 Nov 2017	Published in enforcement report	+8 days

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

Reason for recall

Presence of Foreign Tablets/Capsules.

Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.

Product as listed by the FDA

Paroxetine Tablets, USP, 30mg, 100 tablets (10 x 10) , Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Columbus, Ohio 43217, NDC 68084-046-01

Where it was distributed

Nationwide in the USA

Nationwide

Questions about this recall

Is Paroxetine Tablets, USP, 30mg (10 x recalled?

Yes. Amerisource Health Services recalled Paroxetine Tablets, USP, 30mg (10 x on 24 Oct 2017. The recall is Class II and its status is Terminated. Recall number D-0091-2018.

Why was it recalled?

Presence of Foreign Tablets/Capsules.

Which lots are affected?

Lot 172291

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

More recalls from Amerisource Health Services

All 69

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27 May 2026Drug	CLASS III	Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
1 Apr 2026Drug	CLASS II	Meclizine Hydrochloride Tablets, USP 5 mg, (a) [] recalledMeclizine Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
18 Feb 2026Drug	CLASS II	Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalledOxycodone Hydrochloride	Amerisource Health Services	Packaging Defects	Nationwide
5 Nov 2025Drug	CLASS II	Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride	Amerisource Health Services	Nitrosamine Impurity	Nationwide

Other Paroxetine recalls

All 16

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