Hi-Tech Ciprofloxacin Eye Drops Recalled for Impurities
Hi-Tech Pharmacal recalls specific lots of Ciprofloxacin Ophthalmic Solution due to failed impurity specifications. Check your lot numbers and expiration dates.
Use caution until it’s fixed
Failed Impurities/Degradation Specifications: Firm voluntarily recalled products due to out-of-specification results for an unknown impurity at or near the expiration (24-month).
Contact the company
What happened, in plain English
Actavis Pharma Inc is recalling Ciprofloxacin Ophthalmic Solution because some bottles contain out-of-specification levels of an unknown impurity near the expiration date. The recall affects 447,150 bottles distributed nationwide and in Puerto Rico. Consumers should check their specific lot numbers against the recalled list. Read more at govinfonow.com/recall/43109-hi-tech-ciprofloxacin-eye-drops-recalled-for-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/43109-hi-tech-ciprofloxacin-eye-drops-recalled-for-impurities · Updated October 11, 2026 · FDA enforcement record: FDA #D-1060-2016
Cite this page
“Hi-Tech Ciprofloxacin Eye Drops Recalled for Impurities.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43109-hi-tech-ciprofloxacin-eye-drops-recalled-for-impurities. Based on FDA recall #D-1060-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1060-2016%22&limit=1).
Why it’s dangerous
The product failed specifications for an unknown impurity at or near its expiration date. While the specific health effects of this impurity are not detailed, using medication with failed quality standards can pose a risk to eye health.
Who’s affected
People who have been prescribed or purchased Ciprofloxacin Ophthalmic Solution from Hi-Tech Pharmacal Co. Inc. between the manufacturing dates and expiration dates listed in the record.
How to tell if you have this one
Look for Ciprofloxacin Ophthalmic Solution (0.3% as base), Sterile, Rx only in 2.5 mL, 5 mL, or 10 mL bottles manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY. Check the NDC numbers (50383-0282-02, 50383-282-05, or 50383-0282-10) and lot numbers such as 626487, 628181, 629827, 630495, 632266, 633683, 347742, 627438, 628080, 628491, 628634, 629141, 631528, 347613, 348175, 628398, 630511, or 347361.
- Brand
Hi-Tech Pharmacal- Category
Drug
What to do — step by step
Check Your Lot Numbers
Compare the lot number and expiration date on your bottle against the recalled list provided in the record.
Stop Using Recalled Bottles
If you have a recalled lot, discontinue use immediately to avoid potential exposure to unknown impurities.
Contact Your Pharmacist or Doctor
Consult your healthcare provider for guidance on replacing the medication or obtaining a refund, as specific remedy details are not provided in this record.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.2 years 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.
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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-1060-2016 (March 16, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1060-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.