August 2025 FDA Recall Duloxetine by Breckenridge Pharmaceutical, Inc.
D-0621-2025 - CGMP deviations
This Class II drug recall was voluntarily initiated by Breckenridge Pharmaceutical, Inc. on August 8, 2025 for the product Duloxetine. The FDA reported the reason for recall as cgmp deviations. The product was distributed in AZ, IN, NJ and the recall is currently ongoing.
Recall Number: D-0621-2025
CGMP deviations: N-nitroso-duloxetine impurity above the proposed interim limit.
08-08-2025
09-17-2025
3,591 bottles
Recall Profile & Regulatory Data
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Breckenridge Pharmaceutical, Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
AZ, IN, NJ
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000 Capsules per bottle, Rx Only, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain. Manufactured for: Quallent Pharmaceuticals Health LLC, Grand Cayman, Cayman Islands. NDC: 82009-030-10
Batch or Lot Expiration Information
Lot# Lot 240927C, Exp 04/30/2027
