The Recall Desk
SevereFDA (Drugs)·D-0097-2019·Announced 2018-10-31

Teva Recalls Paliperidone Extended Release Tablets Due to Missing Laser Drilling

Teva Pharmaceuticals USA is recalling 3,785 bottles of Paliperidone Extended Release Tablets 9 mg because some tablets may be missing laser drilling, which could affect drug release.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II. Per the rubric, FDA Class II recalls are assigned a severity score of 4 (Severe), particularly when involving potential functional defects in drug delivery systems that could impact therapeutic efficacy or safety.

Plain-English summary

Teva Pharmaceuticals USA is recalling 3,785 bottles of Paliperidone Extended Release Tablets 9 mg. The affected product is packaged in 30-count bottles (NDC 0591-3695-30) and 90-count bottles (NDC 0591-3695-19). The tablets are manufactured by Actavis Laboratories FL, Inc. and distributed by Actavis Pharma, Inc. The specific lots involved are 1291192A and 1291193A, both with an expiration date of 01/2020.

The recall was initiated because there is a potential for some tablets to be missing the laser drilling process. This defect might affect the drug release mechanism of the extended-release tablets. The FDA has classified this recall as Class II, indicating that use of, or exposure to, the violative product may cause temporary or medically reversible adverse health consequences.

The product was distributed throughout the United States. Bulk product was also distributed to Takeda in Deerfield, IL, and may have been further distributed. Patients and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed above. If the product is found, it should be returned to the pharmacy or distributor for a refund.

The recalled product

Product
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
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Prescription Medication
Hazard
Affected units
3,785

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 (3)

  • Lot #: a) 1291192A
  • Exp 01/2020
  • b) 1291193A

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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