⚠ RecallRadar📷 ScanGuidesOfficial U.S. recall notices, restated plainly

Breckenridge Pharmaceutical, Inc.: Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only,

DrugsSource: FDA (drug) · Date: 2025-11-05

Read the official notice at FDA (drug) →

Share on XFacebookRedditEmail

Get alerts for Breckenridge Pharmaceutical

Guides: Which agency handles which recall (FDA vs USDA vs CPSC vs NHTSA)

The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Breckenridge Pharmaceutical, Inc.
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, a.) 90-count bottle (NDC: 51991-748-90), b.)1000-count bottle (NDC 51991-748-10),Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain; Dist. by: Breckenridge Pharmaceutical, Inc., Berkeley Heights, NJ 07922.
Reason / hazard
CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.
Classification
Class II
Status
Ongoing
Distribution / sold at
U.S. Nationwide
Recall initiated
2025-10-09
Code info
90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026
Product quantity
172,263 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Berkeley Heights
State
NJ
Country
United States
Event id
97797
Free daily digest + "My products" watchlist

Get the daily digest, and tell us what to watch. Everything is optional except your email.

Free allergen alerts:

Categories:

Privacy: we store only what you enter here, use it only to send recall alerts you asked for, never sell or share it, and you can unsubscribe anytime. Double opt-in: we will email you a confirmation link before sending anything; alerts start only after you confirm. Every email has unsubscribe and manage-watchlist links.