Fentanyl 100mcg Patch (Teva) – Degradation Risk (2018)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), 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 0591-3214-54.
Brand
Teva Pharmaceuticals USA
Lot Codes / Batch Numbers
Lot #: 1096857A, Exp. Feb 2018, 1115872A, Exp. Apr 2018, 1123625A, Exp. May 2018, 1148775A. 1157255A, Exp. Aug 2018, 1169928A, Exp. Nov 2018, 1196300A, Exp. Apr 2019, 1213533A, Exp. Jun 2019.
Products Sold
Lot #: 1096857A, Exp. Feb 2018; 1115872A, Exp. Apr 2018; 1123625A, Exp. May 2018; 1148775A. 1157255A, Exp. Aug 2018; 1169928A, Exp. Nov 2018; 1196300A, Exp. Apr 2019; 1213533A, Exp. Jun 2019.
Teva Pharmaceuticals USA is recalling Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Man due to Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026