Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0096-2019·Announced 2018-10-31

Teva Recalls Paliperidone Extended Release Tablets Due to Defective Delivery System

Teva Pharmaceuticals is recalling 27,816 bottles of Paliperidone Extended Release Tablets 3 mg because some tablets may be missing laser drilling, which could affect drug release.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, and the hazard involves a potential defect in the delivery system that might affect drug release, without reported injuries or illnesses.

Plain-English summary

Teva Pharmaceuticals USA is recalling 27,816 bottles of Paliperidone Extended Release Tablets 3 mg. The product is available in 30-count and 90-count bottles and is prescription only. The tablets are manufactured by Actavis Laboratories FL, Inc., and distributed by Actavis Pharma, Inc.

The recall is due to a defective delivery system. There is a potential for some tablets to be missing the laser drilling, which might affect drug release. The affected lots include 1220221A, 1269627A, 1274295A, 1220222A, 1270501A, 1274296A, and 1288766A, with expiration dates ranging from March 2019 to January 2020.

The product was distributed throughout the United States. Bulk product was also distributed to Takeda in Deerfield, IL, and may have been further distributed. Consumers and healthcare providers should check their inventory for these specific lot numbers and contact their pharmacist or the recalling firm for instructions on how to handle the affected product.

The recalled product

Product: 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
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Antipsychotic
Hazard: defective-delivery-system
inconsistent-drug-release
Affected units: 27,816

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (11)

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

Distribution

Distribution scope not specified by the agency.

Part of a larger recall action

This product is one of 7 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 7 products in this recall →

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