Akorn, Inc. recalls Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake
Akorn recalls Atropine Sulfate Ophthalm: 5mL bottles with stability issues. This medication may not be safe for use as it failed stability testing.
Lower-risk recall
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling Atropine Sulfate Ophthalmic 1% Solution bottles that failed stability testing. This could mean the medication is not safe for use as it may not work properly or could be harmful. Read more at govinfonow.com/recall/40804-akorn-atropine-sulfate-ophthalmic-1-solution-recall-stability-issue.
Source Summary by GovInfoNow · govinfonow.com/recall/40804-akorn-atropine-sulfate-ophthalmic-1-solution-recall-stability-issue · Updated October 7, 2026 · FDA enforcement record: FDA #D-0577-2018
Cite this page
“Akorn Atropine Sulfate Ophthalmic 1% Solution Recall: Stability Issue.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40804-akorn-atropine-sulfate-ophthalmic-1-solution-recall-stability-issue. Based on FDA recall #D-0577-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0577-2018%22&limit=1).
Why it’s dangerous
The medication failed stability testing, indicating it may not be safe for use. This could mean the solution is not effective or could cause harm if used improperly.
Who’s affected
Prescription users of Atropine Sulfate Ophthalmic 1% Solution. Those with the specific bottle size and lot number are most at risk.
How to tell if you have this one
Check for bottles labeled 'Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only' from Akorn, Inc. in Lake Forest, IL. Look for lot number 011037A.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Verify the product label includes 'Atropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only' and lot number 011037A.
Questions people ask
Is this product safe to use?
The recall states the product failed stability testing, so it may not be safe for use.
What should I do if I have this product?
The recall does not specify a remedy, so check with your healthcare provider for guidance.
How can I tell if I have the recalled product?
Look for bottles with lot number 011037A from Akorn, Inc. in Lake Forest, IL.
Contact Akorn
We’ve drafted a message you can send Akorn to request your refund or repair — edit it as you like.
Subject: Recall D-0577-2018 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-0577-2018 from Akorn. 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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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-0577-2018 (February 21, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0577-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.