FDA Drug recall D-0491-2026
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA…
- FDA Drug
- Class II
- ongoing
- Published 2026-05-06
On 2026-05-06 the FDA classified a Class II recall of Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA… by Alcon Research, citing lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0491-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-04-21 |
| Published | 2026-05-06 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Alcon Research |
| Distribution | US |
Product
Systane, Lubricant Eye Gel, Night Gel, Sterile, 10g (0.35 oz), Processed in France for: Alcon Laboratiroes, Inc., Fort Worth, TX 76134, USA, NDC 0065-0474-01
Reason
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Identifiers
| ndc | 0065-0474-01 |
|---|---|
| ndc | 0065-0474-02 |
| code_info | Lot#: 9T21, Exp Date: 4/30/2026; Lot# 1U63, 2U47, Exp Date: 5/31/2026; Lot# 6V00, 6V12, 8V54, Exp Date: 1/31/2027; Lot#…Lot#: 9T21, Exp Date: 4/30/2026; Lot# 1U63, 2U47, Exp Date: 5/31/2026; Lot# 6V00, 6V12, 8V54, Exp Date: 1/31/2027; Lot# 9V55, 8V58, 9V39, 9V97, Exp Date: 2/28/2027; Lot# 1W39, 1W40, Exp Date: 3/31/2027; Lot# 1X76, Exp Date: 4/30/2027. |
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-0491-2026%22
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