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

Source: FDA · United States

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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 this FDA recall tells you, and what most readers miss

This notice was issued by FDA on February 24, 2026 and geographically references United States. Its severity classification of "medium" signals how the issuing agency weighs the risk of harm if no action is taken — "critical" and "high" tier alerts typically carry direct consumer actions, while "medium" and "low" tend toward informational guidance or monitoring advisories. The category it belongs to — FDA Recalls — determines the regulatory framework behind it, which shapes what remedies (refunds, replacements, recalls, evacuations) are available to affected individuals and who holds statutory responsibility for enforcement.

Most readers skim a notice like this, check whether they are personally affected, and move on. The more useful lens is to read it as a data point about the issuing system: how quickly FDA detected the hazard, how precise the geographic or product-identifier scope is, and whether similar notices have clustered in the same category or region in the last 90 days. Cluster patterns frequently precede a broader regulatory action — a single localized FDA recall is isolated; three of them within a quarter often indicate a supply-chain, infrastructure, or seasonal driver that will keep producing notices until something structural changes.

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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.

Original source: FDA Official Notice ↗

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Frequently Asked Questions

Common questions about this FDA recall.

What is this FDA recall 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 updates?
Browse the full FDA Recalls feed on Areazine at areazine.com/recalls/fda/ for the latest updates from FDA and other agencies.