Akorn, Inc. recalls Proparacaine Hydrochloride Ophthalmic Solution, USP, 0.5%, 15 mL per dropper bottle, Sterile, Rx Only, Manufactured by:
Akorn recalls 0.5% Proparacaine Hydrochloride Ophthalmic Solution due to chemical contamination in equipment cleaning residue. This may cause unsafe results for eye procedures.
Lower-risk recall
Chemical contamination; out of specification results obtained for equipment cleaning residue rinse sample
Contact the company & request your remedy
What happened, in plain English
Akorn is recalling 0.5% Proparacaine Hydrochloride Ophthalmic Solution (15 mL dropper bottles) because chemical contamination was found in equipment cleaning residue. This could lead to unsafe results during eye procedures if used improperly. Read more at govinfonow.com/recall/37492-akorn-proparacaine-ophthalmic-solution-recall-chemical-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37492-akorn-proparacaine-ophthalmic-solution-recall-chemical-contamination-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1388-2020
Cite this page
“Akorn Proparacaine Ophthalmic Solution Recall: Chemical Contamination Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37492-akorn-proparacaine-ophthalmic-solution-recall-chemical-contamination-risk. Based on FDA recall #D-1388-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1388-2020%22&limit=1).
Why it’s dangerous
The product was found to have chemical contamination in equipment cleaning residue, which may lead to unsafe results during eye procedures. This contamination could affect the safety of the solution when used for medical purposes.
Who’s affected
Prescription eye drop users who have the specific 0.5% Proparacaine Hydrochloride Ophthalmic Solution (15 mL) from Akorn. Healthcare providers administering the drops are most at risk.
How to tell if you have this one
Check for the 0.5% Proparacaine Hydrochloride Ophthalmic Solution (15 mL) dropper bottle labeled 'Sterile, Rx Only' with NDC 17478-263-12 and Lot 9E52A, expiring 04/2021.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Look for the NDC code 17478-263-12 and lot number 9E52A on the bottle label to confirm if it's affected.
Questions people ask
Is this product safe to use?
The product has been recalled due to chemical contamination in equipment cleaning residue, which may lead to unsafe results during eye procedures. Do not use this product.
How can I tell if I have the recalled product?
Check for the NDC code 17478-263-12 and lot number 9E52A on the bottle label. The product expires 04/2021.
What should I do if I have the recalled product?
The recall does not specify a remedy, so contact Akorn directly for guidance on safe disposal or alternatives.
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-1388-2020 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1388-2020 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-1388-2020 (December 26, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1388-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 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.