Xelpros — Class III drug recall D-0502-2024
Ongoing recall by SUN PHARMACEUTICAL INDUSTRIES INC, reported 2024-05-29, distributed in PA, TX. Failed Release Testing: Out of specification for particulate matter test.
| Recall number | D-0502-2024 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | SUN PHARMACEUTICAL INDUSTRIES INC, Princeton, NJ, United States |
| Recall initiated | 2024-04-22 |
| Classified | 2024-05-20 |
| Reported by FDA | 2024-05-29 |
| Distributed | PA, TX |
| Quantity | 35,069 bottles |
| Reason classes | specification failure |
| NDC | 47335-0317, 47335-0317-90, 47335-0317-92, 47335-0317-94, 47335-0317-98 |
| Lot numbers | HAD3383A |
| Expiration dates | 2024-08-31 |
Product
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind. Ltd., India., NDC 47335-317-90
Reason for recall
Failed Release Testing: Out of specification for particulate matter test.
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-0502-2024. 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.