Aidarex Recalls Ciprofloxacin Eye Drops Due to Impurities
Aidarex Pharmaceuticals recalls specific lots of Ciprofloxacin OPTH 0.3% eye drops due to failed impurity specifications. Check your bottle's lot number and expiration date.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications: Out of specification results for unknown impurity.
Contact the company
What happened, in plain English
Aidarex Pharmaceuticals LLC is recalling a small quantity of Ciprofloxacin Ophthalmic Solution, a generic version of Ciloxan, because the product contains unknown impurities that exceed specification limits. The recall affects only 599 bottles distributed nationwide. No specific remedy or return instructions are provided in the record. Read more at govinfonow.com/recall/42595-aidarex-recalls-ciprofloxacin-eye-drops-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/42595-aidarex-recalls-ciprofloxacin-eye-drops-due-to-impurities · Updated October 9, 2026 · FDA enforcement record: FDA #D-1061-2016
Cite this page
“Aidarex Recalls Ciprofloxacin Eye Drops Due to Impurities.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42595-aidarex-recalls-ciprofloxacin-eye-drops-due-to-impurities. Based on FDA recall #D-1061-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1061-2016%22&limit=1).
Why it’s dangerous
The recalled eye drops failed impurity specifications, meaning they contain unknown degradation products or contaminants above the allowed limits. While the record does not specify the exact health consequences, using pharmaceutical products with failed purity standards can compromise treatment efficacy or introduce unwanted substances into the eye.
Who’s affected
Patients who have been prescribed Ciprofloxacin Ophthalmic Solution and possess bottles from the specific lots listed below. The risk is primarily related to the quality of the medication rather than an immediate physical injury hazard.
How to tell if you have this one
Check your bottle for the brand Aidarex Pharmaceuticals and the NDC numbers 33261-0910-01 or 33261-0614-01. Verify if your lot number is one of the following: 44704-1, 44899-1, 45153-1, 45387-1, 45449-1, 45801-1, 47647-1 (Exp. 10/2016 or 02/2017), 40990-1 (Exp. 05/2016), 45960-1 (Exp. 08/2016), or 45316-1, 45961-1 (Exp. 09/2016).
- Brand
Aidarex Pharmaceuticals- Category
Drug
What to do — step by step
Check Your Bottle Details
Compare the NDC and lot numbers on your Ciprofloxacin OPTH 0.3% bottle against the recalled list provided in this record.
Consult Your Pharmacist
Contact your pharmacy or healthcare provider to determine if you have a recalled lot and what alternative treatment options are available.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Where was this product sold?
The product was distributed nationwide across the United States.
Similar recalls
Latest drug recalls
Keep exploring
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-1061-2016 (June 1, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1061-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 9, 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.