FDA Drug recall D-0502-2024
Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind
- FDA Drug
- Class III
- ongoing
- Published 2024-05-29
On 2024-05-29 the FDA classified a Class III recall of Xelpros (latanoprost ophthalmic emulsion) 0.005%, 125mcg/2.5mL, 2.5 mL bottle, Rx only, Manufactured by: Sun Pharmaceutical Ind by Sun Pharmaceutical Industries, citing failed Release Testing: Out of specification for particulate matter test.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0502-2024 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-04-22 |
| Published | 2024-05-29 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Sun Pharmaceutical Industries |
| Distribution | PA, TX |
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
Failed Release Testing: Out of specification for particulate matter test.
Identifiers
| ndc | 47335-317-90 |
|---|---|
| ndc | 47335-317-98 |
| ndc | 47335-317-92 |
| ndc | 47335-317-94 |
| code_info | Lot #: HAD3383A, Exp 8/31/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0502-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.