Akorn TheraTears Eye Drops Recall: Lack of Sterility Assurance
Akorn recalls TheraTears Extra lubricant eye drops due to lack of sterility assurance. This may pose infection risks if used improperly.
Recall notice
Lack of Assurance of Sterility
Contact the company
What happened, in plain English
Akorn is recalling TheraTears Extra eye drops because they may not be sterile, which could lead to eye infections. This affects specific batches sold between 2021 and 2023. Read more at govinfonow.com/recall/35861-akorn-theratears-eye-drops-recall-lack-of-sterility-assurance.
Source Summary by GovInfoNow · govinfonow.com/recall/35861-akorn-theratears-eye-drops-recall-lack-of-sterility-assurance · Updated August 18, 2026 · FDA enforcement record: FDA #D-0717-2022
Cite this page
“Akorn TheraTears Eye Drops Recall: Lack of Sterility Assurance.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35861-akorn-theratears-eye-drops-recall-lack-of-sterility-assurance. Based on FDA recall #D-0717-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0717-2022%22&limit=1).
Why it’s dangerous
The eye drops may not be sterile, which could lead to infections if they enter the eye. This is a risk because the product is meant for direct use in the eye, where even small contaminants can cause serious issues.
Who’s affected
People who own or use the recalled TheraTears Extra eye drops with the specific lot numbers and expiration date are affected. Those with sensitive eyes or using the product for extended periods are at higher risk.
How to tell if you have this one
Check for the product name 'TheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops' with 30 vials per box. Look for lot numbers 913012, 913013, 913014 and expiration date 1/31/2023.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Identify the lot number and expiration date on the packaging to confirm if it's in the recalled batch.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within theUSA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0717-2022 (September 8, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0717-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.