FDA Class II Recall Issued for Oxycodone Hydrochloride

Key Clinical Summary

• The US Food and Drug Administration (FDA) is monitoring a voluntary, firm-initiated Class II recall of oxycodone hydrochloride tablets, USP (CII), 5 mg, involving 31 676 packages distributed nationwide and identified as Lot #1027932 (Exp. 06/30/2027) and Lot #1028360 (Exp. 08/31/2027).
• The recall was initiated after multiple customer complaints of blister card seal defects, which allowed tablets to fall out of their cavities, a packaging issue that may lead to temporary or medically reversible adverse health consequences.
• Oxycodone 5 mg is a Schedule II opioid analgesic indicated for the management of acute and chronic pain requiring opioid therapy, commonly dispensed in outpatient and inpatient pain management settings.

The FDA has classified a Class II recall for Oxycodone Hydrochloride Tablets, USP (CII), 5 mg, packaged in 100-count (10 × 10) blister cards per carton and distributed under NDC 68084-354-01. The drug product contained in this package is from NDC #10702-018 (KVK-Tech Inc.) and was distributed by American Health Packaging, Columbus, Ohio. The recall affects 31 676 packages, specifically Lot #1027932 (Exp. 06/30/2027) and Lot #1028360 (Exp. 08/31/2027), distributed nationwide in the USA. 

The recall was prompted by multiple customer complaints describing card seal defects in the blister packaging, including weak or non-existent seals. Customers reported that tablets were falling out of their cavities, indicating compromised packaging integrity. The FDA classified the action as Class II on February 13, 2026, meaning the product defect may cause temporary or medically reversible adverse health consequences, though serious harm is unlikely. Notification was issued to consignees by letter; no public press release was issued.

Oxycodone hydrochloride 5 mg is a Schedule II opioid analgesic indicated for the management of acute and chronic pain requiring opioid therapy. Defective blister packaging may increase the risk of dose loss, dispensing errors, and controlled substance accountability concerns. Pharmacists should identify and quarantine affected lot numbers, ensure proper documentation, and secure replacement supply to maintain continuity of pain management while preventing diversion risk.

Reference
FDA. Enforcement Report. February 18, 2026. Accessed February 19, 2026. https://www.accessdata.fda.gov/scripts/ires/index.cfm