Generic Invega Recall Issued Over Extended-Release Problems

Several hundred bottles of generic Invega (paliperidone) have been recalled due to problems with extended-release tablets, which may not enter a patient’s system at the proper rate. 

The generic Invega recall was announced by the FDA and Teva Pharmaceuticals on June 15, indicating that some pills failed test for dissolution.

At first, Teva only recalled the bottles at the retail level in late May. However, last week the recall was extended to the consumer level. There have been no illnesses or adverse health effects reported in association with the recall.

The paliperidone Extended-Release tablets are a generic form of Invega, and are used to treat schizophrenia and schizoaffective disorders.

“Taking a product for the treatment of schizophrenia and schizoaffective disorders that has failed dissolution could result in less drug being absorbed,” the FDA warns. “If two or more consecutive dosing regimens are with affected product, a failure to maintain therapeutic levels could occur, which could reduce effectiveness in treating a patient’s mental and/or mood symptoms, including suicidal thoughts and behavior, self-injurious behavior, mental hospitalizations, assaults, aggressive behavior, as well as vocal and motor tics.”

Teva indicates that the likelihood of taking two or more doses that fail to release appropriately is low.

The recall affects 360 90-count bottles of Paliperidone Extended-Release Tables, 3mg, distributed under the Actavis Pharma Inc. label. The recalled tables have a lot number of 1160682A, an expiration date of 6/2018, and an NDC number of 0591-3693-19. They were distributed between December 12, 2016 and March 16, 2017 nationwide.

Teva issued an Urgent Drug Recall directly to its buyers, asking that drugs still on shelves be returned. Consumers with questions should contact Teva by calling 1-888-836-2872, then selecting option 3, and then option 4. They can also email druginfo@tevapharm.com. They can also report adverse health events through those options or by contacting the FDA MedWatch adverse event reporting program.

In recent years, concerns have emerged about side effects of Invega, and a similar drug, Risperdal, which have been linked to an increased risk of boys and young men developing a rare medical condition known as gynecomastia, which is associated with the growth of breasts, often resulting in the need for surgical removal.

In addition to the physical damages, plaintiffs in hundreds of Invega and Risperdal lawsuits allege that the psychological effects of Risperdal breast growth can have a devastating impact on the boys, greatly impacting their overall quality of life.