RecallRadar

FDA Drug recall D-0216-2026

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrel…

On 2025-12-10 the FDA classified a Class II recall of Duloxetine Delayed-Release Capsules, USP, 60 mg, 1000-Capsule bottles, Rx Only, Manufactured by: Towa Pharmaceuticals Europe, S.L. Marotrel… by Breckenridge Pharmaceutical, citing CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0216-2026
ClassificationClass II
Statusongoing
Initiated2025-11-24
Published2025-12-10
Last updated2026-09-13 11:52 UTC
CompanyBreckenridge Pharmaceutical
DistributionUS

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.

Reason

CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended 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 #: 240534C, Exp. Date 01/2027; 240977C, Exp. Date 04/2027.

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-0216-2026%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.