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# Dr. Reddy’s Recalls Sapropterin Dihydrochloride
- URL: https://www.fdaweb.com/dr-reddys-recalls-sapropterin-dihydrochloride/
- Published: 2024-04-24T12:00:00.000Z
- Updated: 2026-09-14T14:29:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5156838

Dr. Reddy’s Laboratories is recalling six lots of sapropterin dihydrochloride powder for oral solution 100 mg due to powder discoloration in some packets that has led to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints, a [recall notice](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/dr-reddys-issues-voluntary-nationwide-recall-sapropterin-dihydrochloride-powder-oral-solution-100-mg?utm%5Fmedium=email&utm%5Fsource=govdelivery) says. The drug is indicated for reducing blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia due to tetrahydrobiopterin-(BH4-) responsive phenylketonuria.

“Reduced efficacy of the product would result in elevated (Phe) levels in patients,” the notice says. “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.”

To date, Dr. Reddy’s says it has not received any reports of adverse events related to the issue.