Greenpark Spironolactone Ophthalmic Solution Recall: Lack of Sterility Assurance
Greenpark recalls Spironolactone Ophthalmic Solution 0.005 mg/mL bottles due to lack of sterility assurance. This could lead to infections if used improperly. Affected lots from 03012021 to 07132021.
Lower-risk recall
Lack of Assurance of Sterility
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What happened, in plain English
Greenpark is recalling Spironolactone Ophthalmic Solution 0.005 mg/mL bottles because they lack sterility assurance. Using these bottles could lead to eye infections if not properly sterilized. Read more at govinfonow.com/recall/35931-greenpark-spironolactone-ophthalmic-solution-recall-lack-of-sterility-assurance.
Source Summary by GovInfoNow · govinfonow.com/recall/35931-greenpark-spironolactone-ophthalmic-solution-recall-lack-of-sterility-assurance · Updated August 18, 2026 · FDA enforcement record: FDA #D-0804-2021
Cite this page
“Greenpark Spironolactone Ophthalmic Solution Recall: Lack of Sterility Assurance.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35931-greenpark-spironolactone-ophthalmic-solution-recall-lack-of-sterility-assurance. Based on FDA recall #D-0804-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0804-2021%22&limit=1).
Why it’s dangerous
The solution lacks proper sterility assurance, meaning it could become contaminated with bacteria. If used without proper sterilization, this could lead to eye infections or other complications.
Who’s affected
Prescription patients using the recalled Spironolactone Ophthalmic Solution 0.005 mg/mL bottles. Those with eye conditions or recent eye surgery may be at slightly higher risk.
How to tell if you have this one
Check for the lot numbers listed: 03012021, 04132021, 05102021, 06012021, 07012021, 03152021, 06162021, and 07132021. The product is a prescription-only ophthalmic solution sold by Greenpark Compounding Pharmacy.
- Brand
Greenpark- Category
Drug
What to do — step by step
Check Product Lot Number
Look for the lot numbers listed in the recall: 03012021, 04132021, 05102021, 06012021, 07012021, 03152021, 06162021, and 07132021.
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 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-0804-2021 (August 18, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0804-2021 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.