Dr. Reddy’s Laboratories, a leading pharmaceutical company based in Hyderabad, India, announced on Tuesday that it is voluntarily recalling six lots of medication in the United States due to subpotency issues. The affected medication, Sapropterin Dihydrochloride Powder for Oral Solution 100 mg, is indicated to reduce blood phenylalanine (Phe) levels.
The recall was initiated after the company discovered powder discoloration in some packets during an accelerated stability test, which led to decreased potency. Dr. Reddy’s Laboratories emphasized that the issue was also brought to their attention through customer complaints. The decreased potency of the medication poses a risk of elevated Phe levels in patients, which could have serious consequences, including permanent neurocognitive deficits such as intellectual disability, developmental delay, and seizures, particularly in infants and children.
Although there have been no reports of adverse events related to this recall thus far, Dr. Reddy’s Laboratories Inc, the company’s US-based arm, is taking proactive measures. The company is notifying its distributors and customers through recall notification letters and is facilitating the return of all recalled products. Dr. Reddy’s Laboratories advises consumers who possess Sapropterin Dihydrochloride Powder for Oral Solution 100 mg from the affected lots to return it to their place of purchase immediately.
The voluntary recall underscores Dr. Reddy’s Laboratories’ commitment to ensuring the safety and efficacy of its products and maintaining the trust of consumers and healthcare professionals. The company urges individuals with any existing inventory of the recalled product to quarantine it promptly and follow the instructions provided for its return.
