Duloxetine Capsules 60 mg (Amerisource) – Impurity Concern (2024)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Brand
Amerisource Health Services LLC
Lot Codes / Batch Numbers
Lot, expiry: DT6022159A, DT6022167A, DT6022168A, exp 11/30/2024, Lot DT6023034A, 12/31/2024, Lots DT6023050A, DT6023051A, DT6023063A, DT6023067A, exp 01/31/2025, Lots DT6023073A, DT6023072A, exp 02/28/2025
Products Sold
Lot, expiry: DT6022159A, DT6022167A, DT6022168A, exp 11/30/2024; Lot DT6023034A, 12/31/2024; Lots DT6023050A, DT6023051A, DT6023063A, DT6023067A, exp 01/31/2025; Lots DT6023073A, DT6023072A, exp 02/28/2025
Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurob due to CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above the recommended interim limit
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticeDistribution
As reported by FDA
OH, PA, PR
Page updated: Jan 7, 2026