31,400 bottles of seizure drug recalled over possible mix-up with blood-pressure medicine

Annora Pharma has voluntarily recalled about 31,400 bottles of 100mg lacosamide after an FDA notice said some bottles may have been filled with selexipag instead.

The recall affects 60-count bottles from lot numbers A253999 and A254000, both with an expiration date of September 30, 2027. The FDA classified the action as a Class II recall.

Lacosamide is used to treat seizures. Selexipag is used for pulmonary arterial hypertension, a blood-pressure-related condition. A mix-up between the two drugs could leave patients without the medicine they were prescribed or expose them to the wrong active ingredient.

What the FDA notice said

The FDA recall notice, referenced in a June 26 report by the Houston Chronicle, said the affected bottles may have been filled with selexipag instead of lacosamide.

Annora Pharma Private Limited manufactures the product for Camber Pharmaceuticals in Piscataway, New Jersey.

Why the recall matters

This is a medication mix-up recall, not a contamination case. The concern is that patients expecting seizure treatment could receive the wrong drug, with possible treatment failure or unintended side effects.

The FDA's Class II designation means the agency believes the health consequences are likely temporary or reversible, or that serious harm is remote.

What remains unclear

It is not yet clear whether any affected bottles reached patients or pharmacies before the recall, whether the company or FDA has identified the cause of the mix-up, or whether any adverse events have been reported.

The recall adds to the list of supply-chain and manufacturing controls that drugmakers must monitor closely when packaging look-alike medicines.