FDA-Drug2025-02-26Class II
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.
Glenmark Pharmaceuticals Inc., USA
Hazard
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
Sold states
Nationwide within the U.S
Affected count
120,000 bottles
Manufactured in
750 Corporate Dr, N/A, Mahwah, NJ, United States
Products
Atomoxetine Capsules, USP, 10 mg, 30 capsule bottles, Rx Only, Manufactured for: Northstar Rx LLC., Memphis, TN 38141, Manufactured by: Glenmark Pharmaceuticals Ltd., Goa, India, NDC 16714-755-01.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0238-2025Don't want to check this manually?
We email you a Sunday digest of new federal recalls relevant to parents — free, no credit card. Or upgrade to as-it-happens alerts for the brands you actually own.
Get the Sunday Brief