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FDAClass II · Drug · Recalled May 6, 2026
GenTeal Tears 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-0492-2026
- Brand
- Alcon Research
- Classification
- Class II
- Recall status
- Ongoing
- Initiated
- Voluntary: Firm initiated
Description
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.
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 #: 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.
- 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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