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.

Actiq (oral transmucosal fentanyl citrate) 200 mcg Recalled by Teva Pharmaceuticals USA, Inc. Due to Failed Dissolution Specification; during stability testing

Date: May 28, 2013
Company: Teva Pharmaceuticals USA, Inc.
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 Teva Pharmaceuticals USA, Inc. directly.

Affected Products

Actiq (oral transmucosal fentanyl citrate) 200 mcg, lozenge on a stick, a)Single Blister (NDC 63459-502-01), b) 30 count carton (NDC 63459-502-30), Rx only, Manufactured by: Cephalon, Inc., Salt Lake City, UT 84116

Quantity: 316 cartons

Why Was This Recalled?

Failed Dissolution Specification; during stability testing

Where Was This Sold?

This product was distributed to 7 states: FL, IL, MA, MS, MO, OH, TX

Affected (7 states)Not affected

About Teva Pharmaceuticals USA, Inc.

Teva Pharmaceuticals USA, Inc. has 33 total recalls tracked by RecallDetector.

Related Recalls

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