Dr. Reddy's recalls Javygtor (sapropterin dihydrochloride) powder for oral solution due to discoloration indicating decreased potency. Patients should contact their doctor for guidance.
Sub-potent Drug; powder discoloration associated with decreased potency
Dr. Reddy's recalls Javygtor powder for oral solution because it may have discoloration that reduces drug potency. This affects patients using the medication as prescribed by their doctor.
The powder may discolor, which suggests it has lost potency. This means the medication might not work as intended for patients who need it.
Patients prescribed Javygtor by their doctor. Those with specific lot numbers and expiration dates listed in the recall notice are most at risk.
Check the product label for the lot numbers: T2202812 (exp. 07/31/2025), T2204053 (exp. 10/31/2025), T2300975/T2300976 (exp. 02/28/2026), or T2304356 (exp. 08/31/2026).
Talk to your healthcare provider about whether you have the recalled Javygtor product and if you need a different medication.
The product may have discoloration indicating reduced potency, so it's not recommended for use. Consult your doctor for guidance.
Lot numbers T2202812 (exp. 07/31/2025), T2204053 (exp. 10/31/2025), T2300975/T2300976 (exp. 02/28/2026), and T2304356 (exp. 08/31/2026).
Check the product label for the specific lot numbers listed in the recall notice.
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-0485-2024 — Dr. Reddy's Dr. Reddy's Hello, I own a Dr. Reddy's that is covered by recall D-0485-2024 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.
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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.
