CLASS III Drug recall · Reported 14 Feb 2018 · FDA Enforcement Report
Fentanyl Transdermal System, 50 mcg/h recalled by Teva Pharmaceuticals U
Teva Pharmaceuticals U is recalling Fentanyl Transdermal System, 50 mcg/h, distributed nationwide in the US. The recall was initiated on 29 Jan 2018 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0541-2018
- FDA event ID
- 79062
- Recalling firm
- Teva Pharmaceuticals U, North Wales, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 29 Jan 2018
- FDA classified
- 22 Feb 2018
- Reported
- 14 Feb 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Pain Medication
Timeline
| 29 Jan 2018 | Recall initiated by company | |
| 14 Feb 2018 | Published in enforcement report | +16 days |
| 22 Feb 2018 | Classified by FDA | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Distributed nationwide within the United States
Questions about this recall
Is Fentanyl Transdermal System, 50 mcg/h recalled?
Yes. Teva Pharmaceuticals U recalled Fentanyl Transdermal System, 50 mcg/h on 29 Jan 2018. The recall is Class III and its status is Terminated. Recall number D-0541-2018.
Why was it recalled?
Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits
Which lots are affected?
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.
Where was it sold?
Distributed nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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