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Fentanyl Transdermal System. 75 mcg/h Recalled by Teva Pharmaceuticals USA Due to Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the...

Date: January 29, 2018
Company: Teva Pharmaceuticals USA
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 directly.

Affected Products

Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3213-54.

Quantity: 576, 760 (5 pouches/carton)

Why Was This Recalled?

Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Teva Pharmaceuticals USA

Teva Pharmaceuticals USA has 196 total recalls tracked by RecallDetector.

Related Recalls

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