Drug FDA Class II Ongoing Quality

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 68084-35

Amerisource Health Services LLC Published Feb 18, 2026

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

Check whether you have this product, using the lot codes, UPCs, and dates listed below.
Do not eat, serve, or sell the affected product.
Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
Contact Amerisource Health Services LLC or your place of purchase with questions, and see the source record below for full details.

Reason for recall

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

Affected products (1)

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

OXYCODONE HYDROCHLORIDE · 31,676 packages

NDC: 68084-354, 68084-968, 68084-975, 68084-983, 68084-354-11, 68084-354-01, 68084-968-11, 68084-968-01, 68084-975-11, 68084-975-01, 68084-983-11, 68084-983-01

Code info: Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027

Affected areas

Nationwide

Timeline

Initiated

Jan 14, 2026
Published

Feb 18, 2026

Recall number: D-0338-2026
Agency: U.S. Food and Drug Administration
Country: US

Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.