Dr. Reddy’s Laboratories announces voluntary recall of Sapropterin Dihydrochloride due to potency concerns

Dr. Reddy’s Laboratories Ltd., a prominent pharmaceutical company listed on multiple stock exchanges including BSE: 500124 and NYSE: RDY, has initiated a voluntary recall of six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg. This decision comes after discovering discoloration in some packets which could lead to decreased potency of the product. The recall affects products distributed to consumers and spans a critical healthcare concern.

The problem was identified during an accelerated stability test and corroborated by customer complaints, prompting immediate action from the company. The discoloration is believed to affect the medication’s efficacy, posing significant health risks. Patients who rely on this medication are treated for hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-responsive Phenylketonuria (PKU), a condition that requires maintaining low blood phenylalanine levels.

The reduced efficacy of the medication could result in elevated phenylalaninemia (Phe) levels in patients. For infants and children, chronically high Phe levels may lead to permanent neurocognitive deficits, including irreversible intellectual disabilities, developmental delays, and seizures. In pregnant women, elevated Phe levels during early gestation are linked to severe outcomes such as microcephaly and congenital heart disease.

In response to the discovery, Dr. Reddy’s Laboratories Inc. is actively reaching out to distributors and customers through recall notification letters and is managing returns of all affected products. Consumers in possession of the recalled Sapropterin Dihydrochloride Powder are advised to quarantine the lots immediately and consult their healthcare provider before discontinuing use. They are also instructed to return the product to their place of purchase.

To date, Dr. Reddy’s Laboratories Inc. has not received any reports of adverse events related to the recalled products. The company is taking this recall seriously and is committed to ensuring the safety and well-being of all patients using their products.