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Class I · Most seriousActive recall

Javygtor

A reasonable chance it could cause serious harm or death.

Does this affect you?
Check your lot numberLot #: T2202812, Exp. 07/31/2025; T2204053, Exp. 10/31/2025; T2300975, T2300976, Exp. 02/28/2026; T2304356, Exp. 08/31/2026.
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Sub-potent Drug; powder discoloration associated with decreased potency

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byMade in India foreign manufacturer
Brand nameJAVYGTOR
Generic nameSAPROPTERIN DIHYDROCHLORIDE
Active ingredient(s)SAPROPTERIN DIHYDROCHLORIDE
Distributed by / forDr. Reddy's Laboratories, Inc.
NDC43598-097-30
Show the full FDA record
Full product labelJavygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-097-30.
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionNationwide in the USA
Quantity17,332 cartons
Recall initiated2024-04-08
Report date2024-05-15
Recall completed—
Recall numberD-0485-2024
ClassificationClass I
FDA statusOngoing
Origin on filePrinceton NJ United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.