CLASS II Drug recall · Reported 16 Mar 2022 · FDA Enforcement Report

Paliperidone Extended-release Tablets, 9 mg per carton recalled

The Harvard Drug Group is recalling Paliperidone Extended-release Tablets, 9 mg per carton ( blister packs), distributed nationwide in the US. The recall was initiated on 28 Feb 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: N00522, Exp. Date 09/2022; N00618, Exp. Date 11/2022
NDC0904-6935, 0904-6936, 0904-6937
Quantity recalled174 cartons

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-0649-2022
FDA event ID
89681
Recalling firm
The Harvard Drug Group, Livonia, MI
Manufacturer
Major Pharmaceuticals
Classification
Class II
Status
Terminated
Recall initiated
28 Feb 2022
FDA classified
9 Mar 2022
Reported
16 Mar 2022
Type
Voluntary: Firm initiated
Customers notified by
Letter
Reason category
Potency & Assay

Timeline

28 Feb 2022Recall initiated by company
9 Mar 2022Classified by FDA+9 days
16 Mar 2022Published in enforcement report+7 days

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

Reason for recall

Failed Dissolution Specifications

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

PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 blister packs), Rx only, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, India. Distributed by: MAJOR PHARMACEUTICALS, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152. NDC: 0904-6937-61

Where it was distributed

Nationwide within the United States

Nationwide

Questions about this recall

Why was it recalled?

Failed Dissolution Specifications

Which lots are affected?

Lot #: N00522, Exp. Date 09/2022; N00618, Exp. Date 11/2022

Where was it sold?

Nationwide within the United States

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.

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Other Paliperidone recalls

All 5
ReportedClassRecallCompanyReasonWhere
DrugCLASS IIPaliperidone Extended Release Tablets 3 mg recalledTeva Pharmaceuticals USAPackaging DefectsNationwide
DrugCLASS IIPaliperidone Extended Release Tablets 9 mg recalledTeva Pharmaceuticals USAPackaging DefectsNationwide
DrugCLASS IPaliperidone Extended-Release Tablets, 3 mg recalledTeva PharmaceuticalsPotency & AssayNationwide
DrugCLASS IIPaliperidone Extended-release Tablets, 1.5 mg recalledMylan PharmaceuticalsPotency & AssayNationwide