CLASS II ONGOING Drug recall · Reported 18 Feb 2026 · FDA Enforcement Report
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg recalled
Amerisource Health Services is recalling Oxycodone Hydrochloride Tablets, USP (CII), 5 mg (10 x blister cards per, distributed nationwide in the US. The recall was initiated on 14 Jan 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0338-2026
- FDA event ID
- 98308
- Recalling firm
- Amerisource Health Services, Columbus, OH
- Manufacturer
- American Health Packaging
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 14 Jan 2026
- FDA classified
- 13 Feb 2026
- Reported
- 18 Feb 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Pain Medication
Timeline
| 14 Jan 2026 | Recall initiated by company | |
| 13 Feb 2026 | Classified by FDA | +30 days |
| 18 Feb 2026 | Published in enforcement report | +5 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Which lots are affected?
Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Amerisource Health Services
All 69| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS III | Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) [] recalledMeclizine Hydrochloride | Amerisource Health Services | Packaging Defects | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 1 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Prazosin Hydrochloride, Capsules, USP, 2 mg recalledPrazosin Hydrochloride | Amerisource Health Services | Nitrosamine Impurity | Nationwide |
Other Oxycodone recalls
All 19| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Oxycodone and Acetaminophen CII Tablets USP, 7.5 mg/325 mg recalledOxycodone And Acetaminophen | SpecGx | Other | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen CII Tablets USP, 10mg/325 mg recalledOxycodone And Acetaminophen | SpecGx | Other | Nationwide |
| Drug | CLASS III | Oxaydo (oxycodone HCl, USP) tablets, 7.5 mg recalledOxaydo | Zyla Life Sciences US | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Oxycodone Hydrochloride Oral Solution, USP 5 mg per (1 mg/mL) recalled | Akorn | Labeling Errors | Nationwide |