RecallRadar

FDA Drug recall D-0239-2025

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Gle…

On 2025-02-26 the FDA classified a Class II recall of Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Gle… by Glenmark Pharmaceuticals Usa, citing CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0239-2025
ClassificationClass II
Statusongoing
Initiated2025-01-29
Published2025-02-26
Last updated2026-09-13 11:52 UTC
CompanyGlenmark Pharmaceuticals Usa
DistributionUS

Product

Atomoxetine Capsules, USP, 18 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-756-01.

Reason

CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Identifiers

ndc16714-755-01
ndc16714-756-01
ndc16714-757-01
ndc16714-758-01
ndc16714-759-01
ndc16714-760-01
ndc16714-761-01
code_info
Lot Numbers: 19233228, 19233227, Exp.: 7/2025; 19233757, Exp.: 8/2025; 19234229, Exp.: 9/2025; 19235090, Exp.: 11/2025;…Lot Numbers: 19233228, 19233227, Exp.: 7/2025; 19233757, Exp.: 8/2025; 19234229, Exp.: 9/2025; 19235090, Exp.: 11/2025; 19241471, Exp.:3/2026; 19242180, Exp.: 5/2026.

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-0239-2025%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.