Multi-event April 2026 FDA Recall Systane by Alcon Research Llc
This Multi-event Class II drug recall was voluntarily initiated by Alcon Research Llc on April 21, 2026 for the product Systane. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0492-2026
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
04-21-2026
05-06-2026
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Alcon Research LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
GenTeal Tears, Lubricant Eye Gel, Sterile, 10g (0.34 Fl oz), Distributed by: Alcon Laboratories, Inc., Fort Worth, Texas 76134, USA, NDC: 0065-8064-01.
Batch or Lot Expiration Information
Lot# : 9T20, 9T50, 9T59, 1U30, 1U48, Exp Date: 4/30/2026; 4V15, Exp Date: 8/31/2026; 7V61, Exp Date: 12/31/2026; 1W47, 1W49, 1X14, Exp Date: 3/31/2027.
Affected Packages Involved in this Recall
Recall Number: D-0491-2026
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
04-21-2026
05-06-2026
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Alcon Research LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
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.
