Antipsychotic Drug Recall of Risperdal Consta by the Johnsons Over Mold

The injectable drug is manufactured by Alkermes PLC (NASDAQ: ALKS) and marketed by J&J’s Janssen in the United States. We would also note that this is a voluntary recall that is only being conducted by reaching out to doctors who still have the batches under concern.

Drug recalls are often tricky because it is really hard to know exactly who got which batch of pills, and it is hard to know if anything ever happened before, during, or after a recall review. Risperdal Consta is an injectable treatment option for patients suffering from Bipolar I disorder who need longer-term medication treatment.

Please note that J&J’s Janssen warned, “If you are taking a pill called RISPERDAL® (risperidone) or any other dose of RISPERDAL® CONSTA®, then this recall does not apply to you. RISPERDAL® CONSTA® (25 mg) is an injectable medicine given by a healthcare professional.”

So, here is the good news. Only about 5,000 or so of the injectable vials made at the time of this batch under concern were remaining as unused. There also have not been any serious reports from this concern. The bad news is that the recall is over the concern of mold and somewhere around 70,000 vials were made. The company also said that if patients are taking Risperdal Consta then it is important to continue treatment as prescribed and that doctors and treatment teams will continue to have ample supplies of the drug. More information on the voluntary recall can be found at the Risperdal Consta website.

Knowing how or when this arose is no easy task. We would also note that since clinics have to store this themselves, it is possible that the mold concerns might not even be the fault of Johnson & Johnson and maybe not even of Alkermes. Unfortunately, this is also a blockbuster drug with more than $1 billion in annual sales.

Investors should note that Alkermes is worth just a little over $4.7 billion in market value and J&J is worth some $251 billion. This is one of those situations where things might not be as bad as they seem when you first see the headline, but we will leave that decision up to time after more knowledge and data can be determined.