Recalls / Class II
Class IID-0338-2026
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
- Brand name
- Oxycodone Hydrochloride
- Generic name
- Oxycodone Hydrochloride
- Active ingredient
- Oxycodone Hydrochloride
- Route
- Oral
- NDCs
- 68084-354, 68084-968, 68084-975, 68084-983
- FDA application
- ANDA091393
- Affected lot / code info
- Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027
Why it was recalled
Defective container: Multiple customer complaints received for card seal defects observed on the subject lots. Customers reported card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.
Recalling firm
- Firm
- Amerisource Health Services LLC
- Manufacturer
- American Health Packaging
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 2550 John Glenn Ave Ste A, N/A, Columbus, Ohio 43217-1188
Distribution
- Quantity
- 31,676 packages
- Distribution pattern
- Nationwide in the USA
Timeline
- Recall initiated
- 2026-01-14
- FDA classified
- 2026-02-13
- Posted by FDA
- 2026-02-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0338-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.