Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles

Breckenridge Pharmaceutical, Inc. has recalled Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on December 10, 2025 and was initiated on November 24, 2025. It is classified as a Class II recall, which means using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.

Below is a plain-English summary of what was recalled, why it was recalled, how to tell whether you have the affected product, and what steps you can take. For the complete and most current details, you can view the FDA record linked further down this page.

What was recalled?

This recall covers Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, with approximately 7389 bottles affected. The company behind the recall is Breckenridge Pharmaceutical, Inc., based in Berkeley Heights, NJ. The FDA describes the product as: “Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.”

Why was Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles recalled?

According to the FDA, the stated reason for the recall is: “CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit.” In plain terms, this recall relates to a manufacturing quality issue (CGMP).

CGMP stands for Current Good Manufacturing Practice — the FDA's quality rules for how medicines must be made, tested, and documented. A CGMP-related recall means the manufacturing process did not meet those standards. It does not automatically mean the medicine is harmful, but the FDA cannot be confident in its quality, so it is removed from the market.

What should you do?

If you think you may have bought Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, compare it against the product description and identifying codes (Lot #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.) before using it. This recall is currently listed as ongoing.

The general guidance for a matching product is to stop using it and follow the instructions in the official FDA recall notice, which may include a repair, replacement, refund, or safe disposal. When in doubt, contact Breckenridge Pharmaceutical, Inc. or your local health authority.

About this recall

This recall was distributed in NJ. RecallRadar summarizes recall information from public FDA data to make it easier to understand. We are an independent service and are not affiliated with the FDA or any government agency, so please always refer to the official source for the authoritative record — and note the “last synced” date shown on this page, since recall details can change over time.