Oxycodone Hydrochloride Tablets — Class II drug recall D-0338-2026
Ongoing recall by Amerisource Health Services LLC, reported 2026-02-18, distributed nationwide. Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their
| Recall number | D-0338-2026 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Amerisource Health Services LLC, Columbus, OH, United States |
| Recall initiated | 2026-01-14 |
| Classified | 2026-02-13 |
| Reported by FDA | 2026-02-18 |
| Distributed | Nationwide (US) |
| Quantity | 31,676 packages |
| Reason classes | packaging |
| NDC | 68084-0354, 68084-0354-01, 68084-0354-11, 68084-0968, 68084-0968-01, 68084-0968-11, 68084-0975, 68084-0975-01, 68084-0975-11, 68084-0983, 68084-0983-01, 68084-0983-11 |
| Lot numbers | 1027932, 1028360 |
| Expiration dates | 2027-06-30, 2027-08-31 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0338-2026. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.