Duloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity
Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules 30 mg nationwide due to N-nitroso-duloxetine impurity above recommended limits. Patients should contact their healthcare provider.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall without reported illnesses, injuries, or hospitalizations. The recall addresses a manufacturing quality deviation involving N-nitroso impurity above recommended interim limits, representing a risk-of-harm product scenario where injury has not yet been reported, warranting a High severity classification per the rubric.
Plain-English summary
Amerisource Health Services LLC, on behalf of BluePoint Laboratories, is recalling Duloxetine Delayed-Release Capsules USP, 30 mg (NDC 68001-414-04) distributed nationwide in the USA. The recalled product consists of 21,262 bottles with lot number DT3023029A, expiration date February 28, 2025.
The recall was initiated due to a manufacturing quality deviation. Testing revealed the presence of N-nitroso-duloxetine impurity at levels above the recommended interim limit.
Patients taking this medication should contact their healthcare provider for guidance about their prescription, including whether to continue use or switch to an alternative. Return unused portions of the recalled lot to the pharmacy per your provider's instructions.
This is a Class II recall issued by the U.S. Food and Drug Administration.
The recalled product
- Product
- 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
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Hazard
- n-nitroso-impurity
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot DT3023029A Exp 02/28/2025
Distribution
Distributed nationwide across the United States.
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