Dr. Reddy’s announced the recall of six lots of Javygtor™ (sapropterin) 100mg powder for oral solution and their generic version of sapropterin 100mg powder for oral solution.

On April 23, 2024, Dr. Reddy’s announced a recall of six lots for Javygtor™ (sapropterin) 100mg powder for oral solution and their generic version of sapropterin 100mg powder for oral solution. The recall is to the consumer level due to discolored powder in some packets that may also have decreased potency. Since the drug is indicated to reduce blood phenylalanine (Phe) in patients, reduced efficacy of the drug could lead to elevated phenylalaninemia levels. This could potentially lead to permanent neurocognitive effects in infants or children. Elevated levels of Phe in pregnant patients can also lead to complications such as early gestation, microcephaly and congenital heart disease. For more information see here