CLASS III Drug recall · Reported 15 Jun 2022 · FDA Enforcement Report
Xiidra (lifitegrast ophthalmic solution) 5% Professional Sample recalled
Novartis Pharmaceuticals is recalling Xiidra (lifitegrast ophthalmic solution) 5% Professional Sample, distributed nationwide in the US. The recall was initiated on 10 May 2022 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0984-2022
- FDA event ID
- 90176
- Recalling firm
- Novartis Pharmaceuticals, East Hanover, NJ
- Brand
- Xiidra
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 10 May 2022
- FDA classified
- 6 Jun 2022
- Reported
- 15 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Eye Drops
Timeline
| 10 May 2022 | Recall initiated by company | |
| 6 Jun 2022 | Classified by FDA | +27 days |
| 15 Jun 2022 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-95) and b) 4 pouches x 5 single-use containers (NDC 0078-0911-94), Rx Only, Manufactured by: The Ritedose Corporation Columbia, SC 29203; Distributed by: Novartis Pharmaceuticals Corporation East Hanover, NJ 07936.
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications.
Which lots are affected?
Lot #: a) and b) 20DJ3, Exp. Date 03/2023.
Where was it sold?
Nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
3 other products · FDA event 90176This product is part of a recall event; the main page for the event is Xiidra (lifitegrast ophthalmic solution) 5% Professional Sample recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Xiidra (lifitegrast ophthalmic solution) 5% Professional Sample recalled | Novartis Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS III | Xiidra (lifitegrast ophthalmic solution) recalled | Novartis Pharmaceuticals | Potency & Assay | Nationwide | |
| CLASS III | Xiidra (lifitegrast ophthalmic solution) recalledXiidra | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
More recalls from Novartis Pharmaceuticals
All 33| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diovan (valsartan) 160 mg recalled by Novartis PharmaceuticalsDiovan | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalled | Novartis Pharmaceuticals | Other | Nationwide |
| Drug | CLASS I | Sandimmune Oral Solution (cyclosporine oral solution, USP) 100 mg/mL recalled | Novartis Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Neoral soft gelatin capsules (cyclosporine capsules recalledNeoral | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Xiidra (lifitegrast ophthalmic solution) recalledXiidra | Novartis Pharmaceuticals | Potency & Assay | Nationwide |
Other Lifitegrast recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Xiidra (lifitegrast ophthalmic solution) recalledXiidra | Novartis Pharmaceuticals | Potency & Assay | Nationwide |