US Drug Recall Register
Class II · Moderate risk Terminated Initiated Aug 27, 2014 (12 years ago)

OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Failed Tablet/Capsule Specifications: Broken tablets found in sealed bottles.

What was recalled

OXYCODONE and ACETAMINOPHEN, USP 10 mg/325 mg, CII, 100 TABLETS, Rx only, Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC 0603-4982-21

Recalling firm
Qualitest Pharmaceuticals
NDC code
0603-4982-21
Origin
AL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-1572-2014

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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