FDA Recall D-0491-2026

Alcon Research LLC · Fort Worth, TX

Class II Ongoing 23 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: 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.

Reason for recall

Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.

Recall record

Recall number: D-0491-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the United States
Recall initiated: 2026-04-21
Classified by FDA Center: 2026-04-24
FDA published: 2026-05-06
Recalling firm: Alcon Research LLC
Firm location: Fort Worth, TX

Drug identification

Brand name(s): SYSTANE
Generic name(s): HYPROMELLOSE
Manufacturer(s): Alcon Laboratories, Inc.
NDC(s): 0065-0474
Route(s): OPHTHALMIC

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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