FDA Issues Class II Recall for Duloxetine Due to Nitrosamine Impurity
The US Food and Drug Administration (FDA) has issued a Class II recall for multiple lots of Duloxetine Delayed-Release Capsules, USP, 60 mg, packaged in 1000-capsule bottles, due to the presence of N-nitroso-duloxetine, a nitrosamine impurity found above FDA-recommended safety limits. The affected product was manufactured by Towa Pharmaceuticals Europe, S.L. in Barcelona, Spain, and distributed in the US under 2 labels:
- Quallient Pharmaceuticals Health, LLC (NDC 82009-032-10)
- Breckenridge Pharmaceutical, Inc. (NDC 51991-748-10)
The recall includes a total of 10 786 bottles across three impacted lots: 240947C, 240962C, 240534C, and 240977C, all with expiration dates in 2027. The voluntary recall began on November 21, 2025, and the products were distributed nationwide in the US.
The FDA classified the recall as Class II on December 3, 2025, indicating that use of the product may cause temporary or medically reversible adverse health consequences, though the risk of serious injury is considered low. Nitrosamines are classified as probable human carcinogens, and while the immediate risk is minimal, long-term exposure above recommended intake levels could pose health concerns. There have been no reported adverse events linked to this recall, but out of an abundance of caution, Breckenridge Pharmaceutical, Inc. initiated the recall and notified customers by letter.
Duloxetine is a serotonin-norepinephrine reuptake inhibitor (SNRI) indicated for the treatment of major depressive disorder, generalized anxiety disorder, diabetic peripheral neuropathy, fibromyalgia, and chronic musculoskeletal pain. Pharmacists are advised to identify and quarantine affected lots, counsel patients on the situation if affected, and coordinate with prescribers to offer alternative therapeutic options.
Reference
FDA. Enforcement Report. December 3, 2025. Accessed December 4, 2025. https://www.accessdata.fda.gov/scripts/ires/index.cfm
