Drug recalls

Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India,…

Glenmark Pharmaceuticals Inc., USA · CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.

Class IIOngoingD-0231-2025
Status
Ongoing
City
Mahwah
State
NJ
Country
United States
Classification
Class II
Product type
Drugs
Event ID
96194
Recalling firm
Glenmark Pharmaceuticals Inc., USA
Address 1
750 Corporate Dr
Address 2
N/A
Postal code
07430-2009
Voluntary mandated
Voluntary: Firm initiated
Initial firm notification
Letter
Distribution pattern
Nationwide within the U.S
Recall number
D-0231-2025
Product description
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA, Product of India, NDC 68462-265-30.
Product quantity
70,032 bottles
Reason for recall
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Recall initiation date
20250129
Center classification date
20250220
Report date
20250226
Code info
Lot Numbers: 19232368, Exp:5/2025; 19235088, Exp.: 11/2025; 19241447, Exp.: 3/2026; 19243146, Exp.: 7/2026.
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Data from openFDA, FDA's public API. FDA says not to rely on it to make decisions about medical care and to treat every result as unvalidated; confirm against FDA's own record and the product labeling. Not medical or legal advice.