Teva Recalls Fentanyl Transdermal Systems Due to Impurity Exceeding Limits
Teva Pharmaceuticals USA is recalling Fentanyl Transdermal Systems 25 mcg/h because a degradation product exceeded specification limits.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The agency classified this as an FDA Class III recall, which is defined as unlikely to cause adverse health consequences. The hazard is a chemical impurity exceeding limits, but no specific injuries or illnesses are reported in the source text.
Plain-English summary
Teva Pharmaceuticals USA is recalling Fentanyl Transdermal Systems, 25 mcg/h, packaged in 5 pouch system cartons. The recall is due to the presence of the degradation product Fentanyl-n-Oxide (FNO) exceeding established specification limits.
The affected product is distributed nationwide within the United States. The recall covers specific lot numbers with expiration dates ranging from March 2018 to August 2019. The total quantity involved is 1,118,046 units, packaged as 5 pouches per carton.
Consumers and healthcare providers should stop using the affected lots and contact their healthcare provider or pharmacist for guidance on alternative pain management options. The product is prescription-only and should not be discarded in household trash without proper disposal instructions.
The recalled product
- Product
- 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.
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Transdermal Patch
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (20)
- 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
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Teva Pharmaceuticals USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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