Novartis recalls Xiidra 5% ophthalmic solution due to failed impurities and degradation specifications. Affected lots from 2019-2023; Rx only. Consumers should contact Novartis for details.
Failed Impurities/Degradation Specifications.
Novartis is recalling Xiidra 5% ophthalmic solution because it failed impurities and degradation tests. This could pose a risk to eye health if used improperly. The product is prescription-only and affected specific lots with expiration dates from May 2022 to February 2023.
The product failed impurities and degradation specifications, meaning it may contain harmful substances or break down in a way that could affect eye health. This is a quality issue that could lead to irritation or other eye problems if the solution is used.
Prescription users of Xiidra 5% ophthalmic solution who have the affected lots (NDC 54092-606-01 or 54092-606-06) with expiration dates from May 2022 to February 2023. People with dry eye syndrome or other eye conditions requiring this medication are most at risk.
Check the product label for the NDC code 54092-606-01 (60 single-use containers) or 54092-606-06 (5 single-use containers). Look for expiration dates between May 2022 and February 2023 as listed in the recall notice.
Look for the NDC code 54092-606-01 or 54092-606-06 on the packaging.
Reach out to Novartis for specific instructions on what to do with the recalled product.
The recall indicates the product failed impurities and degradation tests, so it may not be safe. Do not use the affected lots until Novartis provides further instructions.
Contact Novartis directly for guidance on how to handle the recalled product, as they will provide specific instructions.
Check the NDC code on the label (54092-606-01 or 54092-606-06) and the expiration date, which should be between May 2022 and February 2023.
We’ve drafted a message you can send Novartis to request your refund or repair — edit it as you like.
Subject: Recall D-0983-2022 — Novartis Novartis Hello, I own a Novartis that is covered by recall D-0983-2022 from Novartis. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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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.
