Warning
Breckenridge Pharmaceutical Recalls Duloxetine Delayed-Release Capsules
This is a Class II recall. This product may cause temporary health problems or pose a slight threat of a serious nature.
Source: FDA
WarningRecall #D-0216-2026Drug / Pharmaceutical
Breckenridge Pharmaceutical Recalls Duloxetine Delayed-Release Capsules
Breckenridge Pharmaceutical, Inc. · Class II — Moderate Risk
Product Description
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.
Reason for Recall
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
FDA Classification
Class II — Moderate Risk
A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
Distribution
Nationwide within the United States
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
The FDA classified this recall as Class II, indicating the pharmaceutical product may cause temporary health problems or poses a slight threat of a serious nature. Breckenridge Pharmaceutical, Inc. initiated the recall on November 24, 2025 affecting 7389 bottles. CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit. The product was distributed nationwide. Consumers should check their purchases and discontinue use of any affected product. Contact Breckenridge Pharmaceutical, Inc. for further instructions.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.