Multi-event November 2025 FDA Recall Duloxetine by Breckenridge Pharmaceutical, Inc.
This Multi-event Class II drug recall was voluntarily initiated by Breckenridge Pharmaceutical, Inc. on November 24, 2025 for the product Duloxetine. The FDA reported the reason for recall as cgmp deviations; presence of n-nitroso-duloxetine impurity above the fda recommended limit. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0216-2026
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
11-24-2025
12-10-2025
7389 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
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical Inc., Berkeley Heights, NJ 07922 NDC 51991-748-10.
Batch or Lot Expiration Information
Lot# : 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.
Affected Packages Involved in this Recall
Recall Number: D-0215-2026
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
11-24-2025
12-10-2025
3397 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
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrelles, (Barcelona), Spain, Manufactured for : Quallient Pharmaceuticals Health, LLC, Grand Cayman, Cayman Islands, NDC 82009-032-10.
Batch or Lot Expiration Information
Lot# : 240947C, 240962C, Exp. Date 04/2027
