FDA Recall D-0240-2025

Glenmark Pharmaceuticals Inc., USA · Mahwah, NJ

Class II Ongoing 470 days on record

Moderate impact — Class II recall — temporary or medically reversible adverse health consequence possible; remote probability of serious adverse health consequence.

Product

Atomoxetine Capsules, USP, 25 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-757-01.

Lot / code: Lot Numbers: 19232506, 19232397, 19232415, Exp.: 5/2025; 19233791, Exp.: 8/2025; 19234248, Exp.: 9/2025; 19240909, Exp.: 2/2026; 19242598, Exp.:6/2026; 19243163, 19243122, Exp.: 7/2026; 19243884, Exp.: 9/2026.

Quantity: 133,824 bottles

Reason for recall

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

Recall record

Recall number: D-0240-2025
Classification: Class II
Status: Ongoing
Voluntary or mandated: Voluntary: Firm initiated
Firm notification: Letter
Distribution: Nationwide within the U.S
Recall initiated: 2025-01-29
Classified by FDA Center: 2025-02-20
FDA published: 2025-02-26
Recalling firm: Glenmark Pharmaceuticals Inc., USA
Firm location: Mahwah, NJ

Drug identification

Brand name(s): ATOMOXETINE
Generic name(s): ATOMOXETINE
Manufacturer(s): Northstar Rx LLC
NDC(s): 16714-755, 16714-756, 16714-757, 16714-758, 16714-759, 16714-760, 16714-761
Route(s): ORAL

Operational response

Class II recalls indicate possible temporary or reversible health consequences. Remove affected lots from active dispensing. Segregate inventory. Check the firm’s recall notification for guidance on patient outreach.

For the official FDA enforcement record, see FDA's Recall Search.

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