Xiidra — Class III drug recall D-0985-2022
Terminated recall by Novartis Pharmaceuticals Corporation, reported 2022-06-15, distributed nationwide. Failed Impurities/Degradation Specifications.
| Recall number | D-0985-2022 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Novartis Pharmaceuticals Corporation, East Hanover, NJ, United States |
| Recall initiated | 2022-05-10 |
| Classified | 2022-06-06 |
| Reported by FDA | 2022-06-15 |
| Terminated | 2024-02-28 |
| Distributed | Nationwide (US) |
| Quantity | 279,179 vials |
| Reason classes | specification failure |
| NDC | 54092-0606-04, 54092-0606-07 |
| Expiration dates | 2022-06, 2022-10, 2023-03 |
Product
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.
Reason for recall
Failed Impurities/Degradation Specifications.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0985-2022. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.