Direct Rx Moxifloxacin Eye Drops: Impurities May Cause Harm
Direct Rx recalls 0.5% moxifloxacin eye drops due to failed impurities and degradation tests. Products with specific lot numbers and expiration dates are affected. Consumers should check their packaging for details.
Lower-risk recall
Failed impurities/degradation specifications
Contact the company
What happened, in plain English
Direct Rx is recalling certain moxifloxacin eye drops because they failed impurities and degradation tests. This could lead to potential harm if used improperly. Read more at govinfonow.com/recall/35212-direct-rx-moxifloxacin-eye-drops-impurities-may-cause-harm.
Source Summary by GovInfoNow · govinfonow.com/recall/35212-direct-rx-moxifloxacin-eye-drops-impurities-may-cause-harm · Updated August 18, 2026 · FDA enforcement record: FDA #D-0637-2022
Cite this page
“Direct Rx Moxifloxacin Eye Drops: Impurities May Cause Harm.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35212-direct-rx-moxifloxacin-eye-drops-impurities-may-cause-harm. Based on FDA recall #D-0637-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0637-2022%22&limit=1).
Why it’s dangerous
The eye drops failed impurities and degradation specifications, meaning they may contain harmful substances or break down in a way that could cause harm. This is a quality issue that affects the safety of the product.
Who’s affected
People who purchased the recalled eye drops from Direct Rx or Aurobindo Pharma USA, Inc. are affected. Those with the specific lot numbers and expiration dates listed are most at risk.
How to tell if you have this one
Check the product label for the lot numbers: 18JA2218, 20DE2104, or 08NO2111, and expiration dates of 6/30/23. The product is a 0.5% moxifloxacin ophthalmic solution, 3 mL.
- Brand
Direct Rx- Category
Drug
What to do — step by step
Check Product Label
Look for the lot numbers 18JA2218, 20DE2104, or 08NO2111 and expiration date 6/30/23 on the packaging.
Where it went and when
Where it was distributed
Distributed in Florida.
FDA distribution: “Florida” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 20 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.
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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-0637-2022 (February 17, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0637-2022 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.