Class I Recall for Hyperphenylalaninemia Drug

A Class I recall has been issued for 6 lots of potentially subpotent sapropterin dihydrochloride powder for oral solution distributed throughout the United States by Dr Reddy’s Laboratories. The US Food and Drug Administration (FDA) included the recall in its May 15, 2024, Enforcement Report.

The FDA’s most serious recall classification, a Class I designation warns that use of the affected product could cause serious adverse health consequences or death. The prescription drug is indicated to reduce blood phenylalaninemia (Phe) levels in patients 1 month of age and older with hyperphenylalaninemia due to tetrahydrobiopterin-responsive phenylketonuria.

“Reduced efficacy of the product would result in elevated Phe levels in patients,” Dr Reddy’s explained in an April 23, 2024, statement. “Chronically elevated Phe levels in infants and children are likely to cause permanent neurocognitive deficits, including permanent and irreversible intellectual disability, developmental delay, and seizures. Furthermore, elevated Phe levels during pregnancy, especially in early gestation, are associated with microcephaly and congenital heart disease.”

The recall affects the following products, which were made in India:

• Javygtor (sapropterin dihydrochloride) powder for oral solution 100 mg, 30 individual packets per carton (NDC 43598-097-30), from lots T2202812 (Exp. 7/31/25), T2204053 (Exp. 10/31/25), T2300975 (Exp. 2/28/26), T2300976 (Exp. 2/28/26), and T2304356 (Exp. 8/31/26); and
• sapropterin dihydrochloride powder for oral solution 100 mg, 30 individual packets per carton (NDC 43598-477-30), from lot T2200352 (Exp. 12/31/24).

Dr Reddy’s voluntarily initiated the recall April 8, 2024, after customer reports and an accelerated stability test identified powder discoloration associated with decreased potency in some packets. The FDA designated the recall Class I on May 6, 2024.

As of mid-April, Dr Reddy had not received any reports of adverse events related to the recall.