Sapropterin Dihydrochloride Powder for Oral Solution 100mg — Class I drug recall D-0486-2024
Ongoing recall by Dr. Reddy's Laboratories, Inc., reported 2024-05-15, distributed nationwide. Sub-potent Drug; powder discoloration associated with decreased potency
| Recall number | D-0486-2024 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2024-04-08 |
| Classified | 2024-05-06 |
| Reported by FDA | 2024-05-15 |
| Distributed | Nationwide (US) |
| Quantity | 2,402 cartons |
| Reason classes | potency |
| NDC | 43598-0477-30 |
| Lot numbers | T2200352 |
| Expiration dates | 2024-12-31 |
Product
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 43598-477-30.
Reason for recall
Sub-potent Drug; powder discoloration associated with decreased potency
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0486-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.