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FDAClass II · Drug · Recalled May 6, 2026
Systane recall — Alcon Research LLC
Hazard: Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Class II: may cause temporary or medically reversible health consequences.
View the official FDA enforcement record (openFDA) ↗
- Official recall ID
- D-0491-2026
- Brand
- Alcon Research
- Classification
- Class II
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
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
Affected products
Companies & origin
- Recalling firm location
- Fort Worth, TX, United States
- Firm address
- 6201 South Fwy, 76134-2099
Identifying details (verbatim from the notice)
- Product codes / lots
- 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.
- Distribution
- Nationwide within the United States
- Firm notified the public via
- Letter
- FDA event ID
- 98815
- Recall initiated
- April 21, 2026
- FDA classified
- April 24, 2026
- FDA report date
- May 6, 2026
Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim;
the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.
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