Systane Lubricant Eye Drops — Class I drug recall D-0200-2025
Ongoing recall by Alcon Research LLC, reported 2025-01-22, distributed nationwide. Non-Sterility
| Recall number | D-0200-2025 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Alcon Research LLC, Fort Worth, TX, United States |
| Recall initiated | 2024-12-18 |
| Classified | 2025-01-13 |
| Reported by FDA | 2025-01-22 |
| Distributed | Nationwide (US) |
| Reason classes | sterility |
| Lot numbers | 10101 |
| Expiration dates | 2025-09-30 |
Product
Systane Lubricant Eye Drops, Ultra PF, Sterile, 25 Vials (0.7mL Each), Manufactured for: Alcon Laboratories, Inc. Forth Worth, TX 76134
Reason for recall
Non-Sterility
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-0200-2025. 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.