FDA-Drug2025-01-01Class II
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04
Hazard
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit.
Sold states
Nationwide in the USA
Affected count
20,734 30-count bottles
Manufactured in
2550 John Glenn Ave Ste A, Columbus, OH, United States
Products
Duloxetine Delayed-Release Capsules USP, 60 mg, Rx only, 30 count bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-04
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0157-2025More 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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