Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency

Dr. Reddy’s Issues Voluntary Nationwide Recall of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg Due to Sub-Potency

FOR IMMEDIATE RELEASE Hyderabad India and Princeton, NJ, US; April 23, 2024 – Dr. Reddy’s Laboratories Ltd. (BSE: 500124, NSE: DRREDDY, NYSE: RDY, NSEIFSC: DRREDDY, along with its subsidiaries together referred to as “Dr. Reddy’s”), today announced that it is voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to powder discoloration in some packets leading to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints.

Risk Statement: Reduced efficacy of the product would result in elevated Phenylalaninemia (Phe) levels in patients. 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.