American Health Packaging Recalls Oxycodone Hydrochloride Tablets Due to Defective Blister Seals

FDA Recalls medium FDA · · United States

Amerisource Health Services LLC has recalled 31,676 packages of Oxycodone Hydrochloride tablets due to defective blister card seals that allow tablets to fall out of their packaging.

What Happened

Amerisource Health Services LLC has initiated a voluntary Class II recall of Oxycodone Hydrochloride Tablets, USP (CII), 5 mg. The recall follows multiple customer reports of defective container seals. Specifically, the blister cards were found to have weak or non-existent seals, causing tablets to fall out of their individual cavities.

Which Products Are Affected

The recall affects the following product distributed nationwide in the United States:

  • Product Name: Oxycodone Hydrochloride Tablets, USP (CII), 5 mg
  • Packaging: 100-Count (10 x 10) blister cards per carton
  • NDC Number: 68084-354-01
  • Affected Lots: 1027932 (Expiration 06/30/2027) and 1028360 (Expiration 08/31/2027)
  • Quantity: 31,676 packages
  • Manufacturer: American Health Packaging (Columbus, Ohio)

What You Should Do

Consumers, pharmacists, and healthcare providers should immediately inspect their stock for the affected lot numbers. Amerisource Health Services LLC initiated the notification process via letter on January 14, 2026. If you possess the recalled product, follow the instructions provided in the notification letter for returns and handling.

Why This Matters

Defective packaging for prescription medications can lead to compromised product integrity or accidental ingestion if tablets are separated from their labeled containers and secure blister cards.

Source

Information provided by the FDA under recall number D-0338-2026.

Source: FDA Official Notice

Frequently Asked Questions

What is this fda recalls alert about?
Amerisource Health Services LLC has recalled 31,676 packages of Oxycodone Hydrochloride tablets due to defective blister card seals that allow tablets to fall out of their packaging.
Which agency issued this alert?
This alert was issued by FDA. The original notice is available at the source link at the bottom of this article.
How severe is this alert?
This alert is classified as "medium" severity. Stay informed and follow agency guidance.
What area is affected?
This alert affects United States. Check with FDA for the most current geographic scope.
Where can I find more fda recalls alerts?
Browse all fda recalls alerts on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.