Akorn, Inc. recalls Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%, 15 mL bottle, Rx only, Mfd. by: Akorn, Inc., Lake Forest,
Akorn recalls 2.5% phenylephrine eye drops (15mL) for possible contamination. The product may not be sterile, posing a risk of infection. Consumers should contact Akorn for details.
Lower-risk recall
Lack of Assurance of Sterility: Out of specification results for container closure test which cannot guarantee the sterility of the product.
Contact the company & request your remedy
What happened, in plain English
Akorn has recalled 2.5% phenylephrine hydrochloride ophthalmic solution (15mL bottles) because the product may not be sterile. This could lead to eye infections if used. The recall is for prescription-only products. Read more at govinfonow.com/recall/37919-akorn-recalls-phenylephrine-eye-drops-due-to-possible-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37919-akorn-recalls-phenylephrine-eye-drops-due-to-possible-contamination-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1883-2019
Cite this page
“Akorn recalls Phenylephrine eye drops due to possible contamination risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37919-akorn-recalls-phenylephrine-eye-drops-due-to-possible-contamination-risk. Based on FDA recall #D-1883-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1883-2019%22&limit=1).
Why it’s dangerous
The product failed sterility tests during manufacturing, meaning it might not be sterile. If used, it could cause eye infections or other infections. This is a risk for people who have the specific lot number.
Who’s affected
Prescription users of the 2.:5% phenylephrine eye drops. Those with the specific lot number (031908A) and expiration date (03/20) are most at risk.
How to tell if you have this one
Check for the 15mL bottle labeled 'Phenylephrine Hydrochloride Ophthalmic Solution, USP, 2.5%'. Look for the lot number 031908A and expiration date 03/20 on the label.
- Brand
Akorn- Category
Drug
What to do — step by step
Check Product Details
Look for the lot number 031908A and expiration date 03/20 on the bottle label.
Questions people ask
Is this product safe to use?
The product may not be sterile, so it could cause eye infections. Do not use if you have the specific lot number.
How can I get a replacement?
The recall record does not specify a replacement process.
What should I do if I have this product?
Check the product details for the lot number and expiration date. If it matches, contact Akorn for instructions.
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-1883-2019 — Akorn Akorn Hello, I own a Akorn that is covered by recall D-1883-2019 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-1883-2019 (September 20, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1883-2019 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.