FDA-Drug2025-01-01Class II
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
Amerisource Health Services LLC
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Sold states
Nationwide in the USA
Affected count
13,678 bottles
Manufactured in
2550 John Glenn Ave Ste A, Columbus, OH, United States
Products
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, 90 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-05
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0156-2025Don'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