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Class III · Lower riskRecall completed

Sapropterin Dihydrochloride Powder for Oral Solution

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberT2100891, Exp. 02/28/2024
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

Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.

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
Distributed by / forDr. Reddy's Laboratories, Inc.
NDC43598-477-11
Show the full FDA record
Full product labelSapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).
Recalling firmDr. Reddy's Laboratories, Inc.
DistributionNationwide in the USA.
Quantity340 packets
Recall initiated2022-02-17
Report date2022-03-02
Recall completed2025-01-29
Recall numberD-0640-2022
ClassificationClass III
FDA statusTerminated
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.