Class II · Moderate risk
GenTeal Tears
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Systane (Hypromellose)
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Due to FDA inspection observations that it believes may impact product quality.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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 NDC
0065-0474-01
Compare with the code on your package — it is the most precise check available.
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Systane hypromellose NDC 00065-0474 |
2910 (4000 MPA.S) 3 mg/g | Gel Ophthalmic |
Alcon Laboratories, Inc. | OTC |
- Recalling firm
- Alcon Research LLC
- NDC code
- 0065-0474-01
- Origin
- TX, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0491-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by Alcon Research LLC
All 2026 recalls
Class I · High risk
Systane Lubricant Eye Drops
Non-Sterility
Class II · Moderate risk
TEARS Naturale FREE
Lack of Assurance of Sterility: Some single-use vials may be filled with water rather than the product solution and the firm cannot guarantee the sterility of the water-filled vials.
Other sterility / contamination recalls from 2026
All sterility / contamination recalls
Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Clear Eyes Redness Relief
Lack of Assurance of Sterility
Class II · Moderate risk
Dopamine HCl Inj.
Lack of Assurance of Sterility
Class II · Moderate risk
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
Lack of Assurance of Sterility
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