Teva Fentanyl Transdermal System Recall: Fentanyl-n-Oxide Impurities Risk
Teva recalls Fentanyl Transdermal System (25 mcg/h) due to potential Fentanyl-n-Oxide impurities exceeding safety limits. Rx-only product with specific lot numbers and expiration dates.
Recall notice
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Contact the company
What happened, in plain English
Teva Pharmaceuticals USA is recalling Fentanyl Transdermal System (25 mcg/h) because it may contain unsafe levels of Fentanyl-n-Oxide. This could lead to unintended medication effects if used as intended. Read more at govinfonow.com/recall/40898-teva-fentanyl-transdermal-system-recall-fentanyl-n-oxide-impurities-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/40898-teva-fentanyl-transdermal-system-recall-fentanyl-n-oxide-impurities-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0540-2018
Cite this page
“Teva Fentanyl Transdermal System Recall: Fentanyl-n-Oxide Impurities Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/40898-teva-fentanyl-transdermal-system-recall-fentanyl-n-oxide-impurities-risk. Based on FDA recall #D-0540-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0540-2018%22&limit=1).
Why it’s dangerous
The product may contain Fentanyl-n-Oxide, a degradant that exceeds safety limits. This could cause unintended medication effects if the product is used as intended.
Who’s affected
Prescription patients using the recalled Fentanyl Transdermal System (25 mcg/h) with specific lot numbers and expiration dates. Patients who have been prescribed this medication are most at risk.
How to tell if you have this one
Check for the product name 'Fentanyl Transdermal System' (25 mcg/h) in 5 pouch cartons with NDC 0591-3198-72. Look for specific lot numbers listed in the recall notice, such as 1103907A through 1225166A.
- 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) |
What to do — step by step
Check Product Details
Identify the product by checking the NDC code 0591-3198-72 and specific lot numbers listed in the recall notice.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Distributed nationwide within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- Published in FDA’s Enforcement Report
- FDA classified it Class III
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Is this product safe to use?
The recall states the product may contain unsafe levels of Fentanyl-n-Oxide, so it is not recommended for use until the recall is addressed.
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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.
- Plain-language summary written by qwen3:4b on October 7, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- 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.