Class II U.S. Food and Drug Administration

Amerisource Health Services LLC Oxycodone Hydrochloride Tablets, USP , 5 mg recall: Defective container: card seal defects (weak/non-existent seals)

Recall published 8 months ago

Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.

The hazard: Fall or tip-over hazard

The recall is about structural failure — a frame, joint, leg or lock that does not hold under ordinary use.

What the notice says: Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.

Why it matters: The product can tip, collapse or give way under normal use. Furniture tip-overs in particular kill and injure young children, usually when a child climbs on an open drawer.

Symptoms and when to call a doctor

After a fall or a tip-over involving a child, watch for a headache that gets worse, repeated vomiting, drowsiness that is hard to rouse, confusion, unequal pupils, clear fluid from the nose or ear, or a seizure, and call 911 if any of these appear. Any fall onto the head in a baby under one, or any loss of consciousness at any age, needs to be assessed the same day.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0338-2026
Published
February 18, 2026
Risk level
Class II
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
Amerisource Health Services LLC
Product type
Prescription & OTC drugs
Units affected
31,676 packages
Distribution
Nationwide
Made in
United States
Lot / code info
Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027

Products covered by this recall

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

Check your product

The notice names 10 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Best-by / use-by date

Printed beside the lot code, not on the price sticker.

  • 06
  • 30
  • 2027
  • 1028360
  • 31

NDC number

On the carton and again on the bottle or blister label.

  • 10702-018
  • 68084-354-01
  • 68084-354-11

Package size

Match the net weight or the piece count on the front of the pack.

  • 5 mg
  • 100 Count

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Fall

Amerisource Health Services LLC — The recall is about structural failure — a frame, joint, leg or lock that does not hold under ordinary use.

  1. Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.
  2. Anchor tall furniture to the wall with a tip-over restraint — this is worth doing for every chest and bookcase in the house, not just this one.
  3. Keep TVs, toys and anything else tempting off the top of tall furniture, because that is what draws a child to climb.
  4. Inspect similar units from the same range, since a weak joint or fastener usually affects a whole production run.

How the remedy works

CPSC recalls specify one of three remedies, and which one you get is not negotiable — but how smoothly it goes often is.

  • A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.
  • Return shipping is the company’s cost. If you are asked to pay it, push back.
  • A repair kit is shipped free and is designed to be fitted at home; if you cannot fit it, ask whether they will arrange installation.
  • A replacement is usually the current model, not the recalled one. Confirm the replacement is not itself under recall.

Company contact: Amerisource Health Services LLC — 2550 John Glenn Ave Ste A, Columbus, OH, 43217-1188

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was Amerisource Health Services LLC prescription & otc drugs recalled?

Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities. Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: best-by date 06 or 30. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop using the product and, if it is furniture, move it out of a child’s room until the remedy is done.

Can I get my money back?

A refund means the purchase price back, sometimes prorated by age for durable goods. Ask how they calculated it if the figure looks low.

Where was the recalled product sold?

It was distributed nationwide.

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