Reported May 15, 2024 · Ongoing
Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only,…
Dr. Reddy's Laboratories, Inc.
High riskUsing this product could cause serious injury, illness or death — stop using it now.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Dr. Reddy's Laboratories, Inc. · 107 College Rd E · Princeton, NJ · 08540-6623
Is this the product you have?
- Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only
- DistributorDr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30
- Lot codes and dates
Lot #: T2202812Exp. 07/31/2025T2204053Exp. 10/31/2025T2300975T2300976Exp. 02/28/2026T2304356Exp. 08/31/2026
- Amount recalled
- 17,332 cartons
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Stop using this product now
Sub-potent Drug; powder discoloration associated with decreased potency
Using this product could cause serious injury, illness or death — stop using it now.
Want the full recall guide?
The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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