Alvogen Recalls Oxycodone/Acetaminophen Tablets Due to Dosage Issues
Alvogen recalls specific lots of Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg due to failed content uniformity specifications.
Use caution until it’s fixed
Failed Content Uniformity Specifications - The lot failed to meet the acceptance criteria for Uniformity of Dosage Units at the time of release for the oxycodone component.
Contact the company
What happened, in plain English
Alvogen, Inc. is recalling 8,964 bottles of Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg because the product failed to meet acceptance criteria for the uniformity of dosage units for the oxycodone component. This means the amount of active drug in each tablet may not be consistent with what is labeled. The recall affects bottles distributed nationwide with lot number 453289 and an expiration date of 08/31/15. Read more at govinfonow.com/recall/45773-alvogen-inc-recalls-oxycodone-and-acetaminophen-tablets-usp-10-mg.
Source Summary by GovInfoNow · govinfonow.com/recall/45773-alvogen-inc-recalls-oxycodone-and-acetaminophen-tablets-usp-10-mg · Updated October 12, 2026 · FDA enforcement record: FDA #D-1607-2014
Cite this page
“Alvogen Recalls Oxycodone/Acetaminophen Tablets Due to Dosage Issues.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/45773-alvogen-inc-recalls-oxycodone-and-acetaminophen-tablets-usp-10-mg. Based on FDA recall #D-1607-2014 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1607-2014%22&limit=1).
Why it’s dangerous
The recall was issued because the product failed content uniformity specifications, meaning the quantity of oxycodone in individual tablets may vary significantly from the labeled amount. This inconsistency can lead to under-dosing, which may result in inadequate pain relief, or over-dosing, which increases the risk of side effects associated with opioid medications.
Who’s affected
Patients who have been prescribed or possess the specific recalled bottles of Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg. Individuals relying on these tablets for pain management are at risk of receiving an incorrect dose.
How to tell if you have this one
Check your medication bottles for the following details: Brand/Distributor Alvogen Inc; Product Oxycodone and Acetaminophen Tablets USP 10 mg/325 mg; NDC #47781-0230-01; Lot # 453289; Expiration Date 08/31/15; Package size 100 count bottles.
- Brand
Alvogen- Category
Drug
What to do — step by step
Check Your Medication
Verify if your bottle matches the recalled NDC #47781-0230-01, Lot # 453289, and expiration date 08/31/15.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacist or healthcare provider immediately 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 8 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.
Questions people ask
How many bottles are affected by this recall?
Approximately 8,964 bottles of 100-count packages are being recalled.
Where was the product distributed?
The product was distributed nationwide across the United States.
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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-1607-2014 (August 28, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1607-2014 to see it in context.
- Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.