FDA recall D-0338-2026

Product

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

Reason for recall

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

Distribution

Nationwide in the USA

Key facts

Status

Ongoing

Initiation date

2026-01-14

Report date

2026-02-18

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0338-2026