January 2026 FDA Recall Oxycodone Hydrochloride by Amerisource Health Services Llc
D-0338-2026 - Defective container
This Class II drug recall was voluntarily initiated by Amerisource Health Services Llc on January 14, 2026 for the product Oxycodone Hydrochloride. The FDA reported the reason for recall as defective container. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0338-2026
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
01-14-2026
02-18-2026
31,676 packages
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Amerisource Health Services LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide in the USA
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027
