RecallRadar

FDA Drug recall D-0100-2026

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,…

On 2025-11-05 the FDA classified a Class II recall of 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,… by Breckenridge Pharmaceutical, citing CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0100-2026
ClassificationClass II
Statusongoing
Initiated2025-10-09
Published2025-11-05
Last updated2026-09-13 11:52 UTC
CompanyBreckenridge Pharmaceutical
DistributionUS

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

CGMP Deviations: N-nitroso-duloxetine impurity above the safety assessment limit of 12.5ppm.

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_info90-count- Lot # 240721C; Exp. 02/28/2027 1000-count- Lot #230286C; Exp.02/28/2026

Status history

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

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0100-2026%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.