VistaPharm Recalls Oxycodone Oral Solution Due to Leaking Cups
VistaPharm recalls specific lots of Oxycodone Hydrochloride Oral Solution due to defective containers that may leak. Check your medication packaging immediately.
Use caution until it’s fixed
Defective Container: Excess lidding material accumulation between the seal and the cup resulting in the lid not properly adhering and allowing leakage.
Contact the company
What happened, in plain English
VistaPharm, Inc. is recalling Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL because the container lids are not properly adhered. This defect causes excess lidding material accumulation, which allows the liquid medication to leak from the unit dose cups. The recall affects 8,901 cases distributed nationwide. Read more at govinfonow.com/recall/42990-vistapharm-recalls-oxycodone-oral-solution-due-to-leaking-cups.
Source Summary by GovInfoNow · govinfonow.com/recall/42990-vistapharm-recalls-oxycodone-oral-solution-due-to-leaking-cups · Updated October 11, 2026 · FDA enforcement record: FDA #D-0838-2016
Cite this page
“VistaPharm Recalls Oxycodone Oral Solution Due to Leaking Cups.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/42990-vistapharm-recalls-oxycodone-oral-solution-due-to-leaking-cups. Based on FDA recall #D-0838-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0838-2016%22&limit=1).
Why it’s dangerous
The defective container results in the lid not properly adhering to the cup due to excess lidding material. This failure allows the oral solution to leak, which can lead to inaccurate dosing, waste of medication, or potential exposure to others if the packaging fails during normal use.
Who’s affected
Patients prescribed this specific prescription-strength opioid solution and healthcare providers dispensing it are affected. Individuals with the recalled lot number are at risk of receiving product that may leak during handling or storage.
How to tell if you have this one
Look for Oxycodone Hydrochloride Oral Solution, USP 5 mg/5 mL (1mg/ml) manufactured by VistaPharm. The product is shrink-wrapped in 10 unit dose cups x 5 trays per case with NDC 66689-401-50. Specifically check for Lot # 435200 with an expiration date of 01/18.
- Brand
VistaPharm- Category
Drug
What to do — step by step
Check Your Medication
Verify if your Oxycodone Hydrochloride Oral Solution matches the recalled NDC 66689-401-01, Lot # 435200, and expiration date 01/18.
Contact Your Provider
If you have the recalled product, contact your healthcare provider or pharmacy for instructions on replacement or disposal.
Where it went and when
Where it was distributed
Distributed nationwide.
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 2.3 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.
Questions people ask
How many cases of this product are affected?
Approximately 8,901 cases are included in this nationwide recall.
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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-0838-2016 (April 18, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0838-2016 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 11, 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.