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Lower risk Drug recall · FDA · Published January 18, 2017

VistaPharm Potassium Chloride Oral Solution Recall: Leakage Risk

VistaPharm recalls 50-unit dose cups of Potassium Chloride Oral Solution (10%, 20 mEq/15mL) due to potential leakage at the seal. This may cause improper dosing if the solution leaks.

🇺🇸 FDA recall #D-0469-2017DrugVistaPharm ›
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Recalling firmVistaPharm, Inc.7265 Ulmerton Rd · Largo, FL 33771-4809
✎ GovInfoNow plain-language explainer

What happened, in plain English

VistaPharm is recalling 50-unit dose cups of Potassium Chloride Oral Solution (10%, 20 mEq per 15 mL) because the container seal may leak. This could lead to incorrect dosing if the solution leaks, especially since it's a prescription medication. Read more at govinfonow.com/recall/42082-vistapharm-potassium-chloride-oral-solution-recall-leakage-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/42082-vistapharm-potassium-chloride-oral-solution-recall-leakage-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0469-2017

Cite this page

“VistaPharm Potassium Chloride Oral Solution Recall: Leakage Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42082-vistapharm-potassium-chloride-oral-solution-recall-leakage-risk. Based on FDA recall #D-0469-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0469-2017%22&limit=1).

Why it’s dangerous

The unit dose cups may leak at the seal, which could cause the potassium solution to spill. This might lead to incorrect dosing if the patient uses the solution after it has leaked, potentially causing unsafe potassium levels in the body.

Who’s affected

People who have the 50-unit dose cups of Potassium Chloride Oral Solution (NDC 66689-047-01) with lot numbers 437600 (expiring July 2017) or 447100 (expiring October 2017) are affected. Patients using this medication for potassium supplementation are most at risk.

How to tell if you have this one

Check for unit dose cups labeled 'Potassium Chloride Oral Solution, USP, 10%, 20 mEq per 15 mL' with NDC 66689-047-01. The lot numbers are 437600 (expiring July 2017) or 447100 (expiring October 2017).

  • Brand
    VistaPharm
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check for Leaks

    Inspect the seal of the unit dose cup for signs of leakage. If the cup leaks, stop using it immediately.

Where it went and when

Where it was distributed

Distributed in 36 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: yesNHWashington: yesWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: not listedRIMassachusetts: yesMAOregon: yesORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: not listedMDDelaware: not listedDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: not listedARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Domestic: AL, AZ, CA, CO, CT, FL, GA, HI, IA, IL, IN, KS, KY, LA, MA, MI, MN, MO, MS, NC, NE, NH, NJ, NM, NY, OH, OK, OR, PA, TN, TX, UT, VA, WA WI, & WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Arizona, California, Colorado, Connecticut, Florida, Georgia, Hawaii, Illinois, Indiana, Iowa, Kansas, Kentucky, Louisiana, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, Nebraska, New Hampshire, New Jersey, New Mexico, New York, North Carolina, Ohio, Oklahoma, Oregon, Pennsylvania, Tennessee, Texas, Utah, Virginia, Washington, West Virginia, Wisconsin.

Recall timeline

FDA published this recall 28 days after the firm started it.

1. Firm started the recall: Jan 18, 201712. FDA classified it Class II: Feb 6, 201723. Published in FDA’s Enforcement Report: Feb 15, 201732017
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

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-0469-2017 (January 18, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0469-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on October 8, 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