The FDA has announced that Breckenridge Pharmaceutical, Inc. initiated a voluntary recall of Duloxetine Delayed-Release Capsules, USP, 20mg, Rx only, packaged in 500-count bottles, due to the presence of N-nitroso-duloxetine detected above proposed interim impurity limits. Manufactured by Towa Pharmaceutical Europe, S.L. and distributed by Breckenridge, this recall affects lot number 220128, which has an expiration date of December 2024.

Approximately 7,107 bottles were distributed nationwide in the U.S. The FDA classified the recall as Class II, suggesting that while adverse health consequences may be possible, they are typically temporary or reversible.

This recall was prompted by deviations from Current Good Manufacturing Practice (CGMP), specifically related to the detection of a Nitrosamine Drug Substance Related Impurity (NDSRI), including N-nitroso compounds with known genotoxic and carcinogenic risks. Regulatory standards require nitrosamine levels to remain controlled to minimize health risks, especially for drugs taken over extended periods, such as duloxetine.

Breckenridge communicated the recall to distributors via a letter, and the recall remains ongoing as of the latest update. The FDA assigned an Event ID of 95508, reclassifying the recall to reflect CGMP deviations tied to the presence of NDSRIs rather than degradation specifications alone.

Breckenridge has not issued a press release, opting to notify only affected parties directly.