Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

OXYCODONE and ACETAMINOPHEN Recalled by Qualitest Pharmaceuticals Due to Failed Tablet/Capsule Specifications: Broken tablets found in sealed...

Date: August 27, 2014
Company: Qualitest Pharmaceuticals
Status: Terminated
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Qualitest Pharmaceuticals directly.

Affected Products

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

Quantity: 23,544 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Qualitest Pharmaceuticals

Qualitest Pharmaceuticals has 16 total recalls tracked by RecallDetector.

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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report