Teva Pharmaceuticals USA recalls Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by:
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Recall notice
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
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Source Page by GovInfoNow · govinfonow.com/recall/40898-teva-pharmaceuticals-usa-recalls-fentanyl-transdermal-system-25-mcg-h · Recall date January 29, 2018 · FDA enforcement record: FDA #D-0540-2018
Cite this page
“Teva Pharmaceuticals USA recalls Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by:.” GovInfoNow, recall dated January 29, 2018. https://govinfonow.com/recall/40898-teva-pharmaceuticals-usa-recalls-fentanyl-transdermal-system-25-mcg-h. Based on FDA recall #D-0540-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0540-2018%22&limit=1).
How to tell if you have this one
- Brand
Teva Pharmaceuticals USA- Category
Drug
All 4 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Distributed nationwide within the United States
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0540-2018 | Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), 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 0591-3198-54.; Lot #:1103907A, Exp. Mar 2018; 1114170A, Exp. Apr 2018; 1117212A,, Exp. May 2018; 1130863A, 1140570A, Exp. Jul 2018; 1153178A, Exp. Aug 2018; 1153185A, Exp. Sep 2018; 1171608A, Exp. Nov 2018; 1188715A, Exp. Jan 2019; 1193264A, 1208789A, Exp. Apr 2019; 1212340A, 1225166A, Exp. Jul 2019; 1238442A, Exp. Aug 2019. | 1,118,046 (5 pouches/carton) |
| D-0541-2018 | Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3212-72), 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 0591-3212-54.; Lot #: 1103917A, Exp. Feb 2018; 1114192A, Exp. Apr 2018; 1125605A, Exp. Jun 2018; 1138897A, 1153171A, Exp. Aug 2018; 1156261A, Exp. Oct 2018; 1171595A, Exp. Nov 2018; 1179544A, Exp. Jan 2019; 1189531A, Exp. Mar 2019; 1211389A,Exp. May 2019; 1227468A, Exp. Jun 2019; 1231784A, 1232943A, Exp. Sep 2019. | 929,916 (5 pouches/carton) |
| D-0542-2018 | 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.; Lot #: 1107745A, Exp. Mar 2018;1122452A, 1137109A, Exp. Jun 2018; 1144515A, Exp. Oct 2018; 1189477A, Exp. Mar 2019; 1215224A, Exp. Aug 2019. | 576, 760 (5 pouches/carton) |
| D-0543-2018 | 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.; 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. | 554, 562 (5 pouches/carton) |
Contact Teva Pharmaceuticals USA
We’ve drafted a message you can send Teva Pharmaceuticals USA to request your refund or repair — edit it as you like.
Subject: Recall D-0540-2018 — Teva Pharmaceuticals USA Teva Pharmaceuticals USA recalls Fentanyl Transdermal System. 25 mcg/h, pa Hello, I own a Teva Pharmaceuticals USA recalls Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: that is covered by recall D-0540-2018 from Teva Pharmaceuticals USA. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0540-2018 (January 29, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0540-2018 to see it in context.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.