FDA Drug recall D-0338-2026
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this…
- FDA Drug
- Class II
- ongoing
- Published 2026-02-18
On 2026-02-18 the FDA classified a Class II recall of Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, 100-Count (10 x 10) blister cards per carton, Rx Only, The drug product contained in this… by Amerisource Health Services, citing defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0338-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-01-14 |
| Published | 2026-02-18 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Amerisource Health Services |
| Distribution | US |
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
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Identifiers
| ndc | 68084-354-11 |
|---|---|
| ndc | 68084-354-01 |
| ndc | 68084-968-11 |
| ndc | 68084-968-01 |
| ndc | 68084-975-11 |
| ndc | 68084-975-01 |
| ndc | 68084-983-11 |
| ndc | 68084-983-01 |
| code_info | Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0338-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.