Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles
Recalled by Breckenridge Pharmaceutical, Inc.
Class II — moderate
Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
Breckenridge Pharmaceutical, Inc. has recalled Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles, according to data published by the U.S. Food and Drug Administration (FDA). The recall was reported on June 17, 2026 and was initiated on June 4, 2026. 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, 30mg, 1000 Capsule bottles, with approximately 14,729 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, 30mg, 1000 Capsule bottles, Rx only, Manufactured. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-747-10”
Why was Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles recalled?
According to the FDA, the stated reason for the recall is: “CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim 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, 30mg, 1000 Capsule bottles, compare it against the product description and identifying codes (Lot: 241180C, Exp. Date April 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.
Full recall details
- Status
- Ongoing
- Date reported
- June 17, 2026
- Recall started
- June 4, 2026
- Distributed in
- NJ
What you can do
Check whether any product you have matches the description and codes above. If it does, stop using it and follow the instructions in the official recall notice. When in doubt, contact the company or your local health authority.
Quick answers
Why was Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles recalled?+
According to the FDA: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
How serious is this recall?+
Class II — moderate. Using this product might cause a temporary or medically reversible health problem. The chance of serious harm is low.
What should I do if I have Duloxetine Delayed-Release Capsules, USP, 30mg, 1000 Capsule bottles?+
Compare your product against the description and identifying codes on this page. If it matches, stop using it and follow the instructions in the official recall notice — this usually means returning it for a refund or discarding it. When in doubt, contact the company or your local health authority.
Opens the U.S. Food and Drug Administration (FDA) data for this recall.
Recall number: D-0582-2026. Information last synced from the FDA on July 5, 2026.