US Drug Recall Register
Class II · Moderate risk Terminated Initiated Aug 6, 2018 (8 years ago)

Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

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

What was recalled

Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054

Recalling firm
Teva Pharmaceuticals USA
NDC code
0591-3695-30
Origin
PA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0097-2019

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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