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Unrated Drug recall · FDA · Published May 19, 2016

West-Ward Recalls Oxycodone Oral Solution Due to Impurities

West-Ward Columbus Inc recalls specific lots of Oxycodone HCl Oral Solution USP due to failed impurity specifications. Check your bottle's lot number.

🇺🇸 FDA recall #D-1441-2016DrugWest-Ward ›
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Recalling firmWest-Ward Columbus Inc1809 Wilson Rd · Columbus, OH 43228-9579
✎ GovInfoNow plain-language explainer

What happened, in plain English

West-Ward Columbus Inc is recalling 1,182 bottles of Oxycodone HCl Oral Solution USP (5 mg/5 mL) because the product failed impurity and degradation specifications during a 9-month stability test. The affected bottles were distributed nationwide. No remedy or specific health risks are detailed in this record. Read more at govinfonow.com/recall/42606-west-ward-recalls-oxycodone-oral-solution-due-to-impurities.

Source Summary by GovInfoNow · govinfonow.com/recall/42606-west-ward-recalls-oxycodone-oral-solution-due-to-impurities · Updated October 9, 2026 · FDA enforcement record: FDA #D-1441-2016

Cite this page

“West-Ward Recalls Oxycodone Oral Solution Due to Impurities.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42606-west-ward-recalls-oxycodone-oral-solution-due-to-impurities. Based on FDA recall #D-1441-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1441-2016%22&limit=1).

Why it’s dangerous

The recall was initiated because the drug failed impurity and degradation specifications over a 9-month stability period. The record does not explain what specific health hazards or injuries result from these failed specifications.

Who’s affected

Patients prescribed Oxycodone HCl Oral Solution USP by Boehringer Ingelheim Roxane, Inc. who purchased the product nationwide before June 30, 2017. The specific risk to these individuals is not described in the provided record.

How to tell if you have this one

Look for Oxycodone HCl, Oral Solution USP, 5 mg/5 mL in 15 mL bottles. Check for NDC 0054-0390-41 and Lot #560185A with an expiration date of 6/30/2017.

  • Brand
    West-Ward
  • Category
    Drug

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: “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 9 months after the firm started it.

1. Firm started the recall: May 19, 201612. FDA classified it Class III: Jul 14, 201623. Published in FDA’s Enforcement Report: Jul 20, 201634. FDA terminated the recall: Feb 2, 2017420162017
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  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-1441-2016 (May 19, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1441-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 9, 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