RecallRadar

FDA Drug recall D-0308-2025

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Mar…

On 2025-04-09 the FDA classified a Class II recall of Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Mar… by Breckenridge Pharmaceutical, citing CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the recommended interim limit.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0308-2025
ClassificationClass II
Statusongoing
Initiated2025-03-26
Published2025-04-09
Last updated2026-09-13 11:52 UTC
CompanyBreckenridge Pharmaceutical
DistributionUS

Product

Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx Only, 1,000 Capsules per bottle, Manufactured by: Towa Pharmaceutical Europe, S.L., Martorelles, (Barcelona), Spain, Distributed by: Breckenridge Pharmaceutical, Inc., Berkley Heights, NJ 07922, NDC 51991-747-10.

Reason

CGMP Deviations: presence of Nitrosamine Drug Substance Related Impurity (NDSRI), N-nitroso-duloxetine, above the 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 240909C, Exp Date 03/31/2027

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-0308-2025%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.