FDA recall, , Moderate risk
American Health Packaging Oxycodone Hydrochloride Tablets
Oxycodone Hydrochloride Tablets have defective card seals, which can cause tablets to come out of their cavities.
Summary by Recall Canary from the FDA notice
What happened
Amerisource Health Services LLC of Columbus, Ohio is recalling Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, because of defective container card seals. Multiple customer complaints reported weak or non-existent seals, leading to the tablets falling out of their cavities. The recall began January 14, 2026, and was added to the FDA's Enforcement Report on February 10, 2026.
The recalled product was distributed nationwide in the USA. The drug product is from KVK-Tech Inc. and was distributed by American Health Packaging, Columbus, Ohio 43217.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the list below, then check the codes the FDA notice also names.
An NDC (National Drug Code) is usually printed on the drug's label.
- NDC
- 68084-354-01
- 68084-354-11
- Lot code
- 1027932
From the FDA notice
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this package is from NDC # 10702-018, KVK-Tech Inc. Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC 68084-354-01; Blister NDC 68084-354-11
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- Amerisource Health Services LLCColumbus, Ohio
- Hazard
- Packaging defect
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- Event ID
- 98308
- Recall number
- D-0338-2026
- Quantity recalled
- 31,676 packages
All recalls from Amerisource Health Services LLC
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report
Classified by FDA
In FDA's weekly enforcement report
Listed on Recall Canary
Summary updated
