RecallRadar

FDA Drug recall D-0388-2025

Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Onl…

On 2025-04-30 the FDA classified a Class II recall of Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Onl… by Breckenridge Pharmaceutical, citing CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed interim limit.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0388-2025
ClassificationClass II
Statusongoing
Initiated2025-04-14
Published2025-04-30
Last updated2026-09-13 11:52 UTC
CompanyBreckenridge Pharmaceutical
DistributionUS

Product

Duloxetine Delayed-Release Capsules USP, 30 mg, a.) 90-count bottles (NDC# 51991-747-90), b.) 1000-count bottles (NDC 51991-747-10), Rx Only, Manufactured by Towa Pharmaceutical Europe, S.L. Distributed by Breckenridge Pharmaceutical, Inc. Berkeley Heights, NJ 07922

Reason

CGMP Deviations: Presence of Nitrosamine Drug Substance Related Impurity above the proposed 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 # 230201C, exp. date 01/2026 230471C, exp. date 01/2026 230288C, exp. date 01/2026

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-0388-2025%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.