Recall: Sun Pharma BromSite Eye Drops Due to Sterility Risk
Sun Pharma recalls 69,840 bottles of BromSite eye drops due to lack of sterility assurance. Check lot V18E01.
Stop using this now
Bromfenac Ophthalmic Solution, 0.075% (Sterile 5 mL) may have a lack of sterility assurance.
Contact the company
What happened, in plain English
Sun Pharmaceutical Industries is recalling 69,840 bottles of BromSite (bromfenac ophthalmic solution) 0.075% because the product may lack sterility assurance. The affected bottles were distributed nationwide in the United States. No specific remedy or return instructions are currently listed in the record. Read more at govinfonow.com/recall/39231-recall-sun-pharma-bromsite-eye-drops-due-to-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39231-recall-sun-pharma-bromsite-eye-drops-due-to-sterility-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0422-2019
Cite this page
“Recall: Sun Pharma BromSite Eye Drops Due to Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/39231-recall-sun-pharma-bromsite-eye-drops-due-to-sterility-risk. Based on FDA recall #D-0422-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0422-2019%22&limit=1).
Why it’s dangerous
The recall cites a lack of sterility assurance, meaning the eye drops may contain harmful microorganisms. Using non-sterile ophthalmic solutions can lead to serious eye infections or injury.
Who’s affected
Consumers who purchased BromSite eye drops from pharmacies or retailers across the United States between distribution and January 24, 2019. Patients using this prescription medication are at risk of infection due to potential non-sterility.
How to tell if you have this one
Check your bottle for the brand name BromSite, concentration 0.075%, and volume 5 mL. Look for NDC 49708-754-41 and Lot # V18E01 with an expiration date of 05/2020.
- Brand
Sun Pharmaceutical Industries- Category
Drug
What to do — step by step
Stop using the product
Do not use the eye drops if they match the recalled lot number due to sterility risks.
Check your lot number
Verify if your bottle has Lot # V18E01 and NDC 49708-754-41.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 2.1 years after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0422-2019 (January 24, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0422-2019 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.