Sapropterin (Dr. Reddy's – April)

Dr. Reddy's Laboratories Ltd. has recalled six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg. Sapropterin is used to reduce blood levels of a certain amino acid in people with a rare, inherited disorder called phenylketonuria.

This drug is being recalled because discolored powder was found in it during laboratory testing. It may decrease the effectiveness of the product.

As of April 23, 2024, there had been no reports of adverse events related to this recall.

To learn if your medication was recalled, contact your doctor or the pharmacy where you received the medication, or visit the FDA website below.

Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg from a recalled lot should contact their doctor about next steps before stopping use of the product. Recalled medicine should be returned to the place of purchase.

To learn more about this recall, you can take one or more of the steps below.

• Talk to your doctor or pharmacist.
• Call Dr. Reddy's Laboratories at 1-866-733-3952. TTY users should call 711. Help is available Monday through Friday from 9 a.m. to 5 p.m. EST.
• Visit the FDA website.