FDA Recall D-0338-2026

Amerisource Health Services LLC · Columbus, OH

Class II Ongoing 120 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

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

Lot / code: Lots #: 1027932, Exp Date 06/30/2027, 1028360, Exp Date 08/31/2027

Quantity: 31,676 packages

Reason for recall

Defective container: card seal defects (weak/non-existent seals), leading to the tablets falling out of their cavities.

Recall record

Recall number: D-0338-2026
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide in the USA
Recall initiated: 2026-01-14
Classified by FDA Center: 2026-02-13
FDA published: 2026-02-18
Recalling firm: Amerisource Health Services LLC
Firm location: Columbus, OH

Drug identification

Brand name(s): OXYCODONE HYDROCHLORIDE
Generic name(s): OXYCODONE HYDROCHLORIDE
Manufacturer(s): American Health Packaging
NDC(s): 68084-354, 68084-968, 68084-975, 68084-983
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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