FDA Drugs recall ·
Oxycodone Hydrochloride Tablets, USP (CII), 5 mg… recall
- Recall number
- D-0338-2026
- Date
- (initiated January 14, 2026)
- Company / brand
- Amerisource Health Services LLC
2550 John Glenn Ave Ste A, Columbus, OH, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 31,676 packages
- Hazard tags
- Fall
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0338-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.