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-0582-2026Drug / Pharmaceutical
Breckenridge Pharmaceutical Recalls Duloxetine Delayed-Release Capsules
Breckenridge Pharmaceutical, Inc. · Class II — Moderate Risk
Product Description
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
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim 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 June 4, 2026 affecting 14,729 bottles. CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim 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.