Lupin Pharmaceuticals Inc. recalls Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by:
Lupin Pharmaceuticals recalls 0.03% bimatoprost eye drops due to impurities in the solution. This medication is for prescription use only and may pose risks if impurities are present.
Recall notice
Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
Contact the company & request your remedy
What happened, in plain English
Lupin Pharmaceuticals is recalling a specific 0.03% bimatoprost eye drop solution because it contains impurities that could be harmful. This recall affects prescription-only eye drops that may cause adverse reactions if used without proper quality control. Read more at govinfonow.com/recall/37655-lupin-bimatoprost-ophthalmic-solution-0-03-recall-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37655-lupin-bimatoprost-ophthalmic-solution-0-03-recall-impurities-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0635-2020
Cite this page
“Lupin Bimatoprost Ophthalmic Solution 0.03% Recall: Impurities Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37655-lupin-bimatoprost-ophthalmic-solution-0-03-recall-impurities-risk. Based on FDA recall #D-0635-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0635-2020%22&limit=1).
Why it’s dangerous
The medication contains impurities that failed quality specifications. These impurities could potentially cause harm if the solution is used as intended, though the exact risk level isn't clearly stated in the recall.
Who’s affected
Prescription users of this eye drop solution are affected. Those with the specific lot number or expiration date mentioned in the recall are most at risk.
How to tell if you have this one
Check for the 7.5 mL bottle labeled 'Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only'. The specific lot number H801686 and expiration date 12/31/2019 are mentioned in the recall.
- Brand
Lupin- Category
Drug
What to do — step by step
Check Product Details
Look for the 7.5 mL bottle with the specific lot number H801686 and expiration date 12/31/2019.
Questions people ask
Is this product safe to use?
The recall states that impurities were found, but the exact risk level isn't clearly described. The product is not recommended for use until the recall is addressed.
What should I do if I have this product?
The recall does not specify a remedy, so you should contact Lupin Pharmaceuticals for guidance on next steps.
How can I confirm if my product is recalled?
Check the product label for the lot number H801686 and expiration date 12/31/2019. This specific batch is affected.
Contact Lupin
We’ve drafted a message you can send Lupin to request your refund or repair — edit it as you like.
Subject: Recall D-0635-2020 — Lupin Lupin Hello, I own a Lupin that is covered by recall D-0635-2020 from Lupin. 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-0635-2020 (December 13, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0635-2020 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.