Dr. Reddy's recalls 6 lots of PKU drug due to possible potency problems

Dr. Reddy’s issued a voluntary recall of six lots of sapropterin dihydrochloride powder used to treat phenylketonuria (PKU) due to potential potency issues following internal testing and customer complaints of discoloration in some packets.

PKU is a rare inherited disorder that causes the amino acid phenylalanine to build up in the body. 

Sapropterin dihydrochloride is used to reduce elevated phenylalaninemia (Phe) levels in patients which, if left untreated, can cause permanent neurocognitive deficits in infants and children, including permanent and irreversible intellectual disability, developmental delay, and seizures. 

Additionally, high Phe levels during pregnancy have been linked to microcephaly and congenital heart disease.

Dr. Reddy’s said in its recall letter posted to the FDA website that, to date, it hasn’t received any reports of adverse events.

The recall is for 100 milligram dosages of the drug for oral solution and is packaged in individual packets, 30 per carton, distributed nationwide in the U.S. to wholesalers and retailers. Five of the lots were marketed under the name Javygtor.

The Javygtor lots were set to expire between July 2025 and August 2026, while another batch of the drug, simply called sapropterin dihydrochloride powder for oral solution, would have been for expiration in December. 

Unrelated to the recall, the Indian drugmaker was hit by the FDA with Form 483s in the past six months. In January, its Bachupally R&D campus in India was cited with three observations following an FDA inspection that found deficient records-keeping procedures among other records-keeping issues.

In November of last year, the agency handed Dr. Reddy’s a 10-observation Form 483 write-up after an October inspection of the company’s production plant in Telangana, India.