Akorn Atropine Sulfate Ophthalmic Solution 1% Recall: Stability Issue
Akorn recalls 1% Atropine Sulfate Ophthalmic Solution 2mL bottles due to stability failures. The product may not be safe for eye use after expiration.
Lower-risk recall
Failed Stability Specifications: Out of specification test results for viscosity was identified at the 12M stability timepoint.
Contact the company
What happened, in plain English
Akorn is recalling 1% Atropine Sulfate Ophthalmic Solution 2mL bottles because they failed stability tests. This could mean the solution is unsafe for eye use after the expiration date. Read more at govinfonow.com/recall/33985-akorn-atropine-sulfate-ophthalmic-solution-1-recall-stability-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/33985-akorn-atropine-sulfate-ophthalmic-solution-1-recall-stability-issue · Updated August 18, 2026 · FDA enforcement record: FDA #D-0265-2023
Cite this page
“Akorn Atropine Sulfate Ophthalmic Solution 1% Recall: Stability Issue.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33985-akorn-atropine-sulfate-ophthalmic-solution-1-recall-stability-issue. Based on FDA recall #D-0265-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0265-2023%22&limit=1).
Why it’s dangerous
The product failed stability tests, meaning the solution may not be safe for eye use after the expiration date. This could lead to potential eye irritation or other issues if used improperly.
Who’s affected
People with prescriptions for this eye drop are affected. Those who have the product and are using it as directed are most at risk.
How to tell if you have this one
Check for 2mL bottles labeled 'Atropine Sulfate Ophthalmic Solution, USP 1%'. The product was distributed by Akorn with NDC 17478-215-02 and lot number 081031A, expiring 2/28/2023.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Expiration Date
Verify the expiration date on the bottle, which is 2/28/2023 for lot 081031A.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the 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 published this recall 16 days after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have this product?
Check the expiration date. If expired, do not use and contact your doctor for alternatives.
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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-0265-2023 (January 30, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0265-2023 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.