Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L.
Summary
The FDA issued a Class II for Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mf by Breckenridge Pharmaceutical, Inc.. Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit.
Details
Source
Drug Recall
External ID
D-0552-2025
Action Date
2025-08-13
Status
Ongoing
Category
drug
Product Description
Duloxetine Delayed-Release Capsules, USP, 60mg, 1,000-count bottles, Rx Only, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-748-10.
Lot/Code Info: Lot: 230836C, Exp.: 02/28/2026
Quantity Affected: 1,829 60-count bottles
Reason for Recall
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above safety assessment limit
Distribution
U.S Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2025-07-15
Company
Berkeley Heights, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 55 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Breckenridge Pharmaceutical, Inc. has 29 FDA actions in our database, including 29 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Breckenridge Pharmaceutical, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Breckenridge Pharmaceutical, Inc. have FDA actions?
Breckenridge Pharmaceutical, Inc. has 29 FDA actions in our database, including 29 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0552-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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