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Lower risk Drug recall · FDA · Published October 18, 2018

Promise Pharmacy recalls Prednisolone/Gatifloxacin eye drops with precipitate risk

Promise Pharmacy LLC recalls 1%/0.5% Prednisolone and Gatifloxacin Ophthalmic Solution due to potential precipitate. This may affect eye safety. Contact for details.

🇺🇸 FDA recall #D-0239-2019DrugPromise Pharmacy ›
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Recalling firmPromise Pharmacy LLC31818 US Highway 19 N · Palm Harbor, FL 34684-3713
✎ GovInfoNow plain-language explainer

What happened, in plain English

Promise Pharmacy LLC is recalling prednisolone and gatifloxacin eye drops that may contain precipitate. This could cause eye irritation or injury if used. Read more at govinfonow.com/recall/39489-promise-pharmacy-recalls-prednisolone-gatifloxacin-eye-drops-with-precipitate-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/39489-promise-pharmacy-recalls-prednisolone-gatifloxacin-eye-drops-with-precipitate-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0239-2019

Cite this page

“Promise Pharmacy recalls Prednisolone/Gatifloxacin eye drops with precipitate risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39489-promise-pharmacy-recalls-prednisolone-gatifloxacin-eye-drops-with-precipitate-risk. Based on FDA recall #D-0239-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0239-2019%22&limit=1).

Why it’s dangerous

Precipitate can form in the eye drop solution, potentially causing irritation or injury when used. This is a chemical issue that may not be visible to the user.

Who’s affected

People with prescriptions for these eye drops from Promise Pharmacy in Palm Harbor, Florida. Those with the specific lot number 04092018@2 are most at risk.

How to tell if you have this one

Check for the 3 mL dropper bottle labeled Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%. The lot number 04092018@2 is associated with this recall.

  • Brand
    Promise Pharmacy
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot number 04092018@2 on the bottle label to confirm if it's affected.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “U.S.A. 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 2 years after the firm started it.

1. Firm started the recall: Oct 18, 201812. Published in FDA’s Enforcement Report: Oct 31, 201823. FDA classified it Class III: Nov 8, 201834. FDA terminated the recall: Oct 22, 2020420182020
  1. Firm started the recall
  2. Published in FDA’s Enforcement Report
  3. FDA classified it Class III
  4. 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-0239-2019 (October 18, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0239-2019 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA