Class II

Drug Recall: Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceu

Breckenridge Pharmaceutical, Inc · December 6, 2024

Reason for Recall

CGMP Deviations: presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Product Description

Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922.

Distribution

Nationwide in the US

States Affected

NATIONWIDE

Quantity Affected

163,883 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0161-2025

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

Breckenridge Pharmaceutical, Inc Drug Recall: Duloxetine Delayed-Release Capsules, USP, 30mg, Rx Only, 90-count bottles (NDC 51991-747-90) Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceu | SafeCheck