Recall archive / FDA company announcement
Dr. Reddy’s: Sapropterin Dihydrochloride Powder for Oral Solution 100 mg — FDA announcement Apr 23, 2024
Published notice; closure not supplied
A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.
Source date Apr 23, 2024. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Sapropterin Dihydrochloride Powder for Oral Solution 100 mg
- Reason
- Decreased Potency
- Classification
- Not supplied
- Recalling firm
- Dr. Reddy’s Laboratories Inc
- Quantity
- Not supplied
- Agency-reported status
- Company recall announcement
- Source record identifier
- 91da8cdf5f10607a
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | 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 |
Match all identifying details in the current notice. A brand name alone is not enough.
Product tables from the announcement
These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.
| 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 |
Announcement retrieved Oct 1, 2026. Official announcement.
Distribution
Not supplied
No US distribution state could be established from this record. Check the official notice.
Dates in the source
- Fda listing date
- Apr 23, 2024
- Company announcement date
- Apr 23, 2024
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.