RecallRadar

FDA Drug recall D-0271-2025

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelo…

On 2025-03-19 the FDA classified a Class II recall of Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelo… by Breckenridge Pharmaceutical, citing CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0271-2025
ClassificationClass II
Statusongoing
Initiated2025-02-28
Published2025-03-19
Last updated2026-09-13 11:52 UTC
CompanyBreckenridge Pharmaceutical
DistributionUS

Product

Duloxetine Delayed-Release Capsules, USP, 20mg, Rx Only, 500-count bottles, Mfr. by: Towa Pharmaceutical Europe, S.L. Martorelles, (Barcelona), Spain, Dist. by: Breckenridge Pharmaceuticals, Inc., Berkeley Heights, NJ 07922. NDC 51991-746-05

Reason

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

Identifiers

ndc51991-746-06
ndc51991-746-90
ndc51991-746-05
ndc51991-747-33
ndc51991-747-90
ndc51991-747-10
ndc51991-748-33
ndc51991-748-90
ndc51991-748-10
ndc51991-750-33
ndc51991-750-90
ndc51991-750-05
ndc51991-750-10
code_infoLot#: 240098C, Expiration: 01/2027.

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.

Other recalls by Breckenridge Pharmaceutical

All Breckenridge Pharmaceutical recalls

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0271-2025%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.