Mylan Bromfenac Eye Drops Recalled for Sterility Risk
Mylan recalls specific lots of Bromfenac Ophthalmic Solution due to failed preservative effectiveness tests. Check your NDC and lot numbers immediately.
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Lack of Assurance of Sterility: Failed preservative effectiveness test
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What happened, in plain English
Mylan Pharmaceuticals is recalling specific lots of Bromfenac Ophthalmic Solution 0.09% because the product failed a preservative effectiveness test, meaning sterility cannot be assured. This applies to both 2.5 mL and 5 mL Rx bottles distributed nationwide. The recall was initiated on January 5, 2016. Read more at govinfonow.com/recall/43297-mylan-bromfenac-eye-drops-recalled-for-sterility-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/43297-mylan-bromfenac-eye-drops-recalled-for-sterility-risk · Updated October 11, 2026 · FDA enforcement record: FDA #D-0585-2016
Cite this page
“Mylan Bromfenac Eye Drops Recalled for Sterility Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43297-mylan-bromfenac-eye-drops-recalled-for-sterility-risk. Based on FDA recall #D-0585-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0585-2016%22&limit=1).
Why it’s dangerous
The lack of assurance of sterility means the eye drops may contain harmful bacteria or fungi. Using non-sterile eye drops can lead to serious eye infections, which can cause significant damage to vision if not treated promptly.
Who’s affected
Patients who have been prescribed Bromfenac Ophthalmic Solution 0.09% by a healthcare provider and purchased it at pharmacies across the United States before or around January 2016.
How to tell if you have this one
Check your bottle for the NDC numbers 0378-7110-35 (2.5 mL) or 00378-7109-35 (5 mL). Verify the lot number and expiration date against this list: Lot 0378-7110-35 AD4819 (Exp 08-2016), AC7894 (Exp 05-2016), AD2527 (Exp 06-2016), AC6330 (Exp 05-2016), AC2330 (Exp 04-2016); and Lot 0378-7109-35 AD4515 (Exp 04-2016) or AC2328 (Exp 01-2016).
- Brand
Mylan- Category
Drug
What to do — step by step
Stop using the eye drops
Do not use any of the recalled Bromfenac Ophthalmic Solution bottles identified in the record.
Contact your pharmacist or doctor
Reach out to where you purchased the medication or your healthcare provider for instructions on replacement or disposal, as specific remedy details are not provided in this record.
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 12 months 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.
Questions people ask
Who manufactured this product?
Mylan Pharmaceuticals, Inc., located in Morgantown, WV, manufactured the product under the Mayne Pharma Usa recall notice.
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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-0585-2016 (January 5, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0585-2016 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.