Sapropterin Dihydrochloride Powder for Oral Solution — Class III drug recall D-0640-2022
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2022-03-02, distributed nationwide. Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
| Recall number | D-0640-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2022-02-17 |
| Classified | 2022-02-28 |
| Reported by FDA | 2022-03-02 |
| Terminated | 2025-01-29 |
| Distributed | Nationwide (US) |
| Quantity | 340 packets |
| Reason classes | potency |
| NDC | 43598-0477-11, 43598-0477-30 |
| Expiration dates | 2024-02-28 |
Product
Sapropterin 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).
Reason for recall
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
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-0640-2022. 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.