CLASS II Drug recall · Reported 31 Oct 2018 · FDA Enforcement Report

Paliperidone Extended Release Tablets 3 mg recalled

Teva Pharmaceuticals U is recalling Paliperidone Extended Release Tablets 3 mg, distributed nationwide in the US. The recall was initiated on 6 Aug 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: a) 1220221A, Exp 03/2019; 1269627A, Exp 09/2019; 1274295A, Exp 10/2019; b) 1220222A, Exp 03/2019; 1270501A, Exp 09/2019; 1274296A, Exp 10/2019; 1288766A, Exp 01/2020

Quantity recalled27,816 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-0096-2019
FDA event ID: 80790
Recalling firm: Teva Pharmaceuticals U, North Wales, PA
Classification: Class II
Status: Terminated
Recall initiated: 6 Aug 2018
FDA classified: 25 Oct 2018
Reported: 31 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Packaging Defects

Timeline

6 Aug 2018	Recall initiated by company
25 Oct 2018	Classified by FDA	+80 days
31 Oct 2018	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

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

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

Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054

Where it was distributed

Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.

Nationwide Illinois

Questions about this recall

Is Paliperidone Extended Release Tablets 3 mg recalled?

Yes. Teva Pharmaceuticals U recalled Paliperidone Extended Release Tablets 3 mg on 6 Aug 2018. The recall is Class II and its status is Terminated. Recall number D-0096-2019.

Why was it recalled?

Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.

Which lots are affected?

Lot #: a) 1220221A, Exp 03/2019; 1269627A, Exp 09/2019; 1274295A, Exp 10/2019; b) 1220222A, Exp 03/2019; 1270501A, Exp 09/2019; 1274296A, Exp 10/2019; 1288766A, Exp 01/2020

Where was it sold?

Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.

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.

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26 Jan 2022Drug	CLASS II	Brinzolamide Ophthalmic Suspension recalled by Teva Pharmaceuticals U	Teva Pharmaceuticals U	Packaging Defects	Nationwide

Other Paliperidone recalls

All 5

Reported	Class	Recall	Company	Reason	Where
16 Mar 2022Drug	CLASS II	Paliperidone Extended-release Tablets, 9 mg per carton recalledPaliperidone	The Harvard Drug Group	Potency & Assay	Nationwide
31 Oct 2018Drug	CLASS II	Paliperidone Extended Release Tablets 9 mg recalled	Teva Pharmaceuticals U	Packaging Defects	Nationwide
19 Jul 2017Drug	CLASS I	Paliperidone Extended-Release Tablets, 3 mg recalled	Teva Pharmaceuticals	Potency & Assay	Nationwide
18 May 2016Drug	CLASS II	Paliperidone Extended-release Tablets, 5 mg recalled	Mylan Pharmaceuticals	Potency & Assay	Nationwide