Akorn recalls sterile eye ointment due to non-sterility issues found during stability testing. Products may contain harmful bacteria from Bacillus cereus group. Affected lots expire June 2022 through September 2022.
Non-Sterility - OOS sterility testing observed during 12-month controlled room temperature stability testing. The microbiological investigation identified the organism as a member of the Bacillus cereus group.
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📍Recalling firmAkorn, Inc.1925 W Field Ct Ste 300 · Lake Forest, IL 60045-4862
“Akorn Artificial Tears Ointment Recall: Non-Sterility Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35994-akorn-artificial-tears-ointment-recall-non-sterility-risk. Based on FDA recall #D-0786-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0786-2021%22&limit=1).
The FDA announced on August 2, 2021, that Akorn, Inc. voluntarily recalled Artificial Tears Ointment and Lubricant Eye Ointment due to non-sterility risks. The agency classified the recall as Class II.
The FDA stated that out-of-specification sterility testing was observed during stability testing for the ointments. A microbiological investigation identified the organism as a member of the Bacillus cereus group.
Context
GovInfoNow's records show Akorn, Inc. has had 64 other recalls on record since August 5, 2014. Recent brand recalls include stability issues for Midazolam Injection reported on April 26, 2023, and Atropine Sulfate Ophthalmic Solution reported on January 30, 2023. Other recent recalls of similar products include K.C. Pharmaceuticals Ultra Lubricating Eye Drops Recall (March 3, 2026), K.C. Pharmaceuticals Sterile Eye Drops AC Recall (March 3, 2026), and K.C. Pharmaceuticals Dry Eye Relief Eye Drops Recall (March 3, 2026).
How to tell if you have this one
Check for the product name 'Artificial Tears Ointment' or 'Lubricant Eye Ointment' with a net weight of 3.5g per tube. Look for lot numbers 9G01A (expiring June 2022), 9H32A (expiring July 2022), or 9K82A/B (expiring September 2022).
Brand
Akorn
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Look for the lot numbers 9G01A, 9H32A, or 9K82A/B on the tube packaging.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Nationwide USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 13 months after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0786-2021 (August 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0786-2021 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.