FDA-Drug2025-01-01Class II
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Sold states
Nationwide in the USA
Affected count
21,262 bottles
Manufactured in
2550 John Glenn Ave Ste A, Columbus, OH, United States
Products
Duloxetine Delayed-Release Capsules USP, 30 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-414-04
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0155-2025More Amerisource Health Services LLC recalls
- FDA-Drug2026-05-27Amerisource Health Services Primidone Tablets recalled for trace Acemetacin contamination
- FDA-Drug2026-05-27Amerisource Primidone 250 mg tablets recalled for cross-contamination with Acemetacin
- FDA-Drug2026-04-01Meclizine Hydrochloride 12.5 mg tablets recalled for failed specifications
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