Novartis Xiidra 5% Professional Sample Recall: Failed Impurities Risk
Novartis recalls Xiidra 5% professional sample vials due to failed impurities and degradation specifications. This medication is for prescription use only and may pose risks if improperly stored.
Recall notice
Failed Impurities/Degradation Specifications.
Contact the company
What happened, in plain English
Novartis is recalling professional-grade Xiidra (lifitegrast ophthalmic solution) 5% samples because they failed impurities and degradation tests. This recall affects healthcare providers who may have received these samples for eye treatments. Read more at govinfonow.com/recall/34729-novartis-xiidra-5-professional-sample-recall-failed-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/34729-novartis-xiidra-5-professional-sample-recall-failed-impurities-risk · Updated August 17, 2026 · FDA enforcement record: FDA #D-0985-2022
Cite this page
“Novartis Xiidra 5% Professional Sample Recall: Failed Impurities Risk.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/34729-novartis-xiidra-5-professional-sample-recall-failed-impurities-risk. Based on FDA recall #D-0985-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0985-2022%22&limit=1).
Why it’s dangerous
The recall is due to failed impurities and degradation specifications in the medication. This means the samples may not meet safety standards for eye treatment, though the exact risk level isn't specified in the notice.
Who’s affected
Healthcare providers who received the recalled Xiidra 5% professional samples for eye treatments are most at risk. Patients using these samples under medical supervision are not affected by this recall.
How to tell if you have this one
Check for Xiidra 5% professional samples with NDC codes 54092-606-07 (5 vials) or 54092-606-04 (4 pouches of 5 vials). These samples were manufactured for prescription use only and have specific lot numbers and expiration dates.
- Brand
Novartis- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide within the United States
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0982-2022 | Xiidra (lifitegrast ophthalmic solution), packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 0078-0911-12) and b) 5- Single-Use Containers (NDC 0078-0911-05) Rx Only, Manufactured by: The Ritedose Corporation, Columbia, SC 29203, Distributed by: Novartis Pharmaceuticals Corporation, East Hanover, NJ 07936.; Lot #:a) and b) 20E21, 20E22, 20E53, 20E54, 20E95, 20E96, 20ED1, 20ED2, 20ED3, 20EK1 Exp. Date 4/2023; 20F27, 20F28, 20F66, 20F67,20FH6, Exp. Date 05/2023; 20G47, 20G48, 20G49, 20G57, 20GB8, 20GE5, 20GE6, Exp. Date 06/2023; 20M41, 20M42, 20M56, 20M66, 20M67, 20MA4, Exp. Date 07/2023; 20S20, 20S22, 20S44, 20S94, Exp. Date 10/2023; 20SA6, 20SA7, 20SE0, Exp. Date 10/2023, 20TE2, 20TG5, Exp. Date 11/2023. | 1,187,092 vials | 0078-0911-05, 0078-0911-12, 0078-0911-95, 0078-0911-94 |
| D-0983-2022 | Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 single-use containers (0.2 mL each vial) (NDC 54092-606-01) and b) 5-Single-Use Containers (NDC 54092-606-06), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.; Lot #: a) and b)19E31, 19E32, 19E85, 19E86, 19EC0, 19EG8 & 19EG9, Exp. Date 05/2022; 19F13, 19FB0 & 19FC5, Exp. Date 6/2022;19G33, 19G34,19GJ8, Exp. Date 07/2022;19M25, 19M26 & 19M68, Exp. Date 08/2022;19NC0, 19NC1, 19NF2,19NF3, Exp. Date 09/2022;19P26, 19P59, 19P60,19P85,19P86 19P87, Exp. Date 10/2022;19S55, 19S03, 19S04, 19S05,19S07, Exp. Date 11/2022; 19T06, 19T60, 19T61, Exp. Date 12/2022; 20A38, 20A39, 20A64, 20A65, 20AA1, 20AA2, 20AC8, 20AC9, 20AE7, Exp. Date 01/2023; 20B24, 20B25, 20B55, 20B56, 20B57 & 20B58, Exp. Date 02/2023 | 1,253,862 vials | — |
| D-0984-2022 | 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.; Lot #: a) and b) 20DJ3, Exp. Date 03/2023. | 279,179 vials | 0078-0911-05, 0078-0911-12, 0078-0911-95, 0078-0911-94 |
| D-0985-2022 | Xiidra (lifitegrast ophthalmic solution) 5% PROFESSIONAL SAMPLE, packaged in a) 5 single-use containers (0.2 mL each vial) (NDC 54092-606-07) and b) 4 pouches x 5 single-use containers (NDC 54092-606-04), Rx Only, Manufactured for: Shire US Inc., 300 Shire Way, Lexington, MA 02421.; Lot #: a) and b) 19F39, Exp. Date 06/2022; 19P27, Exp. Date 10/2022; 20CD1, Exp. Date 03/2023 | 279,179 vials | — |
What to do — step by step
Check Product Details
Look for NDC codes 54092-606-07 or 54092-606-04 on the packaging to identify the recalled samples.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0985-2022 (May 10, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0985-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.