Oxycodone Hydrochloride Tablets recall
FDA recall D-0338-2026 · initiated Jan 14, 2026
Amerisource Health Services LLC recalled Oxycodone Hydrochloride Tablets in Jan 2026 — an FDA Class II recall (D-0338-2026) because Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 31,676 packages
Details
- 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
- Recalling company
- Amerisource Health Services LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jan 14, 2026
- FDA report date
- Feb 18, 2026
Frequently asked
- Was Oxycodone Hydrochloride Tablets recalled?
- Amerisource Health Services LLC recalled Oxycodone Hydrochloride Tablets in Jan 2026 — an FDA Class II recall (D-0338-2026) because Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Oxycodone Hydrochloride Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0338-2026 was: Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
- Is a recalled Oxycodone Hydrochloride Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Oxycodone Hydrochloride Tablets are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0338-2026.