Xiidra (Novartis) - Impurity Specifications (2022)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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.
Brand
Novartis Pharmaceuticals Corporation
Lot Codes / Batch Numbers
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
Products Sold
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
Novartis Pharmaceuticals Corporation is recalling Xiidra (lifitegrast ophthalmic solution) 5%, packaged in a) 60 Single-Use Containers: 12 pouches x 5 due to Failed Impurities/Degradation Specifications.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026