FDA Recall of Children’s Prescription Drug - MedWaste Management FDA Recall of Children’s Prescription Drug - MedWaste Management

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FDA Recall of Javygtor for children and infants

FDA Recall of Children’s Prescription Drug

Independent testing has revealed a discoloration of Sapropterin Dihydrochloride Powder, also known as Javygtor™, leading the FDA to announce a recall the drug. While the FDA has stated that no adverse events have been reported as a result of the discoloration, there is concern regarding the stability and, therefore, effectiveness of the drug. Infants and children receiving the drug but not realizing its intended benefits are at a high risk of elevated Phenylalanine levels, resulting in extremely concerning health outcomes.

SUMMARY

Date of Recall:

Announced: April 23, 2024

Public Notification: April 23, 2024

Name(s) of Drug:

Javygtor™

Sapropterin Dihydrochloride

Company Name:

Dr. Reddy’s Laboratories, Inc.

Drug Indication:

Hyperphenylalaninemia (HPA) due to Tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU)

FDA Recall of Javygtor for children and infants

Product Description

Javygtor™ or Sapropterin Dihydrochloride is packaged in individual packets. The powder is intended to be reconstituted into a liquid and consumed orally. Each dose of powder is packaged in an individual packet, and distributed in cartons containing 30 packets each.

The drug listed in this recall is available by prescription only.

Reason for Recall

Testing revealed that some packets contain discolored powder. There is concern that the changes causing the discoloration may decrease the drug’s potency, leading consumers to receive less than intended. The cause of the discoloration is currently unknown.

Impacts

Patients, particularly infants and children, receiving a less-than-intended dose of this medication are at high risk. The dose required to lower the Phe levels may not be present and could lead to permanent brain damage, cognitive deficits, developmental delay, and seizures.

The babies of pregnant women who require this medication and who receive a lower-than-intended dose are at risk of microcephaly (smaller-than-expected head and brain size) and congenital heart disease.

Recall Lot Information

Consumers who utilize this medication should check their stock immediately and compare the numbers on their packaging with those listed below. If your numbers match those on the chart, read further for instructions on complying with the FDA recall.

Product Name/Description

Lot #

Expiration Date

NDC #

Javygtor™ (Sapropterin)
Dihydrochloride) Powder for Oral
Solution 100 mg

T2202812

07/2025 43598-097-30

T2204053

10/2025

43598-097-30

T2300975

02/2026

43598-097-30

T2300976

02/2026

43598-097-30

T2304356 08/2026

43598-097-30

Sapropterin Dihydrochloride Powder for
Oral Solution 100 mg

T2200352

12/2024

43598-477-30

FDA.gov

Have you found that your medication is part of the recall? Here’s what you should do:

Consumers

  1. If you believe that your medication is part of this recall, call your physician immediately. Notify your physician if you or your child have consumed the recalled medication and if you have noted any health changes.
  2. Monitor your (or your child’s) health for any adverse symptoms and notify your physician if any concerns are noted.
  3. Consumers with questions should contact Dr. Reddy’s Laboratories Inc. at 1-866-733-3952. They are available Monday through Friday from 9:00 a.m. to 5:00 p.m. (EST).
  4. If you are currently experiencing or have experienced an adverse reaction to this medication (listed above), notify your physician immediately and notify the FDA by calling 1-800-332-1088 or completing an online reporting form.
  5. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Retailer

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Dr. Reddy’s Laboratories Inc. at 1-866-733-3952. Notify them of any recalled batches that have already been sold to consumers.
  3. Notify affected consumers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

Wholesaler

  1. Examine all inventory and remove stock affected by the recall immediately.
  2. Contact Dr. Reddy’s Laboratories Inc. at 1-866-733-3952. Notify them of any recalled batches that have already been shipped to retailers.
  3. Notify affected retailers of recalled batches that they have already or will receive.
  4. Contact MedWaste Management for information and assistance with disposing of the recalled medication.

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Tammy McKinney, Nurse Writer Healthcare Content Creator Byline Image

Tammy McKinney, RN, founder of HelpfulHospiceNurse, is a healthcare writer and seasoned registered nurse. With experience in acute care, long-term care, rehabilitation, drug & alcohol, and hospice & palliative care, she combines her medical understanding with her love for writing to educate and inform the public on various health-related topics. You can view a snippet of her portfolio here or contact her directly on LinkedIn!


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