Dr Reddy's recalls six lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg over sub potency
Hyderabad, Princeton: Dr Reddy's Laboratories Ltd. has announced that it is voluntarily recalling six (6) lots of Sapropterin Dihydrochloride Powder for Oral Solution 100 mg to the consumer level due to powder discoloration in some packets leading to decreased potency. The issue was discovered during an accelerated stability test in addition to customer complaints.
Reduced efficacy of the product would result in elevated Phenylalaninemia (Phe) levels in patients. Chronically elevated Phe levels in infants and children are likely to cause permanent neurocognitive deficits, including permanent and irreversible intellectual disability, developmental delay, and seizures. Furthermore, elevated Phe levels during pregnancy, especially in early gestation, are associated with microcephaly and congenital heart disease.
Dr. Reddy’s Laboratories Inc. has not received any reports of adverse events related to this recall to date.
The product is indicated to reduce blood phenylalanine (Phe) levels in adult and pediatric patients one month of age and older with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin-(BH4-) responsive Phenylketonuria (PKU) and is packaged in individual packets, 30 per carton. The affected Sapropterin Dihydrochloride Powder for Oral Solution 100mg lots include the following:
| Product Name | Lot Number | Expiration date | NDC Number |
|
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 |
"Sapropterin Dihydrochloride Powder for Oral Solution 100 mg was distributed nationwide to wholesalers/retailers," the release noted.
"Dr. Reddy’s Laboratories Inc. is notifying its distributors and customers by recall notification letters and is arranging for returns of all recalled products. Anyone with an existing inventory of the product being recalled should examine the product and quarantine any of the recalled lots immediately. Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should contact their physician before stopping use of the product. Consumers who have Sapropterin Dihydrochloride Powder for Oral Solution 100 mg which is being recalled should return it to their place of purchase," the Company stated in a release.
Consumers with questions regarding this recall can contact Dr. Reddy’s Laboratories Inc. by calling 866- 733-3952 during office hours from 9 a.m. to 5 p.m. (EST) Monday through Friday. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• Regular Mail or Fax: Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332- 1088 to request a reporting form, then complete and return to the address on the pre-addressed form or submit by fax to 1-800-FDA-0178.
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
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