Teva Pharmaceuticals USA is recalling over 2 million units of Fentanyl Transdermal System patches (25 mcg/h, 50 mcg/h, 75 mcg/h, and 100 mcg/h) because testing found a degradation chemical, Fentanyl-n-Oxide (FNO), at levels higher than allowed safety specifications. These prescription skin patches, used for chronic pain management, were manufactured by Actavis Laboratories and distributed nationwide. Consumers should consult their healthcare provider or pharmacist regarding the continued use of their current patches and return any unused products to their pharmacy for a refund.
The presence of the chemical degradant Fentanyl-n-Oxide above the specified limit may affect the purity and quality of the medication. While the risk is considered low, impurities in prescription medications can lead to unexpected changes in how the drug works or potential side effects for the patient.
Healthcare provider consultation and pharmacy return
AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.
Sources: FDA iRES · Raw API Response
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