Ophthalmic Drug Xiidra Recalled for Failed Impurity Specifications
Novartis is recalling 1,187,092 vials of Xiidra ophthalmic solution nationwide due to failed impurities and degradation specifications in specific lot numbers.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The hazard involves specification failures (impurities and degradation) rather than a confirmed safety threat. Per the rubric, Class III recalls are typically scored 1-2, and this precautionary recall for quality control issues warrants a Score 2.
Plain-English summary
Novartis Pharmaceuticals Corporation is recalling 1,187,092 vials of Xiidra (lifitegrast ophthalmic solution) nationwide. The recall affects specific lot numbers of both the 60-container and 5-container package sizes (NDC 0078-0911-12 and NDC 0078-0911-05), manufactured by The Ritedose Corporation and distributed by Novartis.
The recall was initiated because these lots failed quality specifications for impurities and degradation. Affected lot numbers with various expiration dates ranging from April 2023 to November 2023 are detailed in the FDA's formal recall notice.
Patients currently using these affected lots are advised to contact their healthcare provider or pharmacist for guidance. Do not discontinue or dispose of medication without consulting your pharmacist to ensure continuity of treatment and proper handling.
The recalled product
- Product
- XIIDRA (LIFITEGRAST)
- Brand
- XIIDRA
- Manufacturer
- Novartis Pharmaceuticals Corporation
- Hazard
- Affected units
- 1,187,092
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Novartis Pharmaceuticals Corporation under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 4 products in this recall →Related recalls
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