VistaPharm Hydrocodone Solution Recalled: Incorrect Class III Labeling
VistaPharm recalls 473mL cherry-flavored hydrocodone/acetaminophen solution due to incorrect labeling as Class III controlled substance instead of Class II. This affects prescription-only bottles with specific NDC and lot numbers.
Recall notice
Labeling: Not Elsewhere Classified; product is incorrectly labeled as Class III controlled substance instead of Class II controlled substance
Contact the company
What happened, in plain English
VistaPharm is recalling cherry-flavored hydrocodone and acetaminophen oral solution bottles that are incorrectly labeled as Class III controlled substances instead of Class II. This labeling error could lead to improper prescription handling and potential misuse by healthcare providers. Read more at govinfonow.com/recall/41372-vistapharm-hydrocodone-solution-recalled-incorrect-class-iii-labeling.
Source Summary by GovInfoNow · govinfonow.com/recall/41372-vistapharm-hydrocodone-solution-recalled-incorrect-class-iii-labeling · Updated October 7, 2026 · FDA enforcement record: FDA #D-1139-2017
Cite this page
“VistaPharm Hydrocodone Solution Recalled: Incorrect Class III Labeling.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41372-vistapharm-hydrocodone-solution-recalled-incorrect-class-iii-labeling. Based on FDA recall #D-1139-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1139-2017%22&limit=1).
Why it’s dangerous
The product is incorrectly labeled as a Class III controlled substance when it should be Class II. This mislabeling could lead to improper prescription handling, potential misuse by healthcare providers, and incorrect regulatory oversight.
Who’s affected
Prescription holders of the 473mL cherry-flavored hydrocodone/acetaminophen solution with NDC 66689-023-16 and lot 494700. Healthcare providers and patients who receive this medication are most at risk due to the labeling error.
How to tell if you have this one
Check for 473mL cherry-flavored bottles with NDC 66689-023-16 and lot number 494700. The product is prescription-only and manufactured by VistaPharm in Largo, Florida.
- Brand
VistaPharm- Category
Drug
What to do — step by step
Check Product Label
Look for the NDC code 66689-023-16 and lot number 494700 on the bottle.
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 19 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- 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
Is this product safe to use?
The product is safe to use but has incorrect labeling that could affect prescription handling. The manufacturer has not provided a remedy for this issue.
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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-1139-2017 (August 17, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1139-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.