Dr. Reddy's recalls 100mg Sapropterin Dihydrochloride Powder for oral solution due to subpotent drug results. This may not provide intended treatment. Check NDC 43598-477-11 or 43598-477-30 for affected products.
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Dr. Reddy's is recalling 100mg Sapropterin Dihydrochloride Powder for Oral Solution because lab tests showed it doesn't contain the correct amount of active ingredient. This could mean the medication isn't as effective as it should be for patients needing it.
The lab tests found the product doesn't contain the correct amount of active ingredient. This means the medication might not work as intended for patients who need it. However, the product is still safe to use and the risk is not severe.
Patients prescribed this medication by a doctor. Those with specific medical conditions requiring this drug are most at risk.
Check for the NDC codes 43598-477-11 (packets) or 43598-477-30 (cartons). The product was made in India and expires February 28, 2024.
Look for the NDC codes 43598-477-11 or 43598-477-30 on the packaging.
Yes, the product is safe but may not be as effective due to subpotent results. Patients should consult their doctor.
Check for NDC codes 43598-477-11 (packets) or 43598-477-30 (cartons) on the packaging.
Contact your doctor to discuss alternatives since the product may not provide the intended treatment.
We’ve drafted a message you can send Dr. Reddy's to request your refund or repair — edit it as you like.
Subject: Recall D-0640-2022 — Dr. Reddy's Dr. Reddy's Hello, I own a Dr. Reddy's that is covered by recall D-0640-2022 from Dr. Reddy's. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
