American Health Packaging Oxycodone Solution Recall: Impurity Risk
American Health Packaging recalls 5mg/5mL oxycodone oral solution due to impurity failure in repackaged lots. This controlled substance is for institutional use only.
Recall notice
Impurity failure at 0-time of the repackaged lot.
Contact the company
What happened, in plain English
American Health Packaging is recalling a specific oxycodone oral solution product due to impurity issues in repackaged lots. This controlled substance is intended for institutional use only and requires immediate attention due to potential safety risks. Read more at govinfonow.com/recall/35209-american-health-packaging-oxycodone-solution-recall-impurity-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/35209-american-health-packaging-oxycodone-solution-recall-impurity-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0652-2022
Cite this page
“American Health Packaging Oxycodone Solution Recall: Impurity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35209-american-health-packaging-oxycodone-solution-recall-impurity-risk. Based on FDA recall #D-0652-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0652-2022%22&limit=1).
Why it’s dangerous
The recall states there was an impurity failure at the time of repackaging the lot. This could mean the product contains harmful substances that might cause adverse effects when used as intended. However, the specific nature of the impurity and its potential impact are not clearly described in the recall notice.
Who’s affected
Institutional users of this prescription opioid solution are most at risk. The product is only available through prescription and for institutional use, so affected individuals would be healthcare facilities or pharmacies.
How to tell if you have this one
Check for the product name 'Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL' with the lot number 1004276. This product was sold with a specific UPC code (01 003 60687 406 40 4) and NDC numbers.
- Brand
American Health Packaging- Category
Drug
What to do — step by step
Check Product Details
Verify the lot number 1004276 and NDC numbers 60687-406-77 (case) and 60687-406-40 (unit dose) on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 17 months 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.
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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-0652-2022 (February 22, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0652-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 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.