Duloxetine Delayed-Release 60 mg Capsules Recalled for N-Nitroso Impurity
Amerisource Health Services is recalling Duloxetine Delayed-Release Capsules 60 mg due to N-nitroso impurity levels exceeding FDA recommended limits. The recall affects 20,734 bottles distributed nationwide.
The agency’s classification
FDA (Drugs): Class II
Class II is 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.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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: FDA Class II recall due to manufacturing deviations with N-nitroso impurity above the recommended interim limit. No illnesses or injuries have been reported, qualifying this as a high-priority situation based on regulatory classification and the inherent risk posed by N-nitroso compounds rather than documented harm.
Plain-English summary
Amerisource Health Services LLC is recalling Duloxetine Delayed-Release Capsules USP, 60 mg (NDC 68001-415-04) manufactured by Aurobindo Pharma Limited. The recall involves Lot DT6023061B with an expiration date of January 31, 2025.
The U.S. Food and Drug Administration identified current good manufacturing practice deviations during the production of this medication. Testing determined that Duloxetine Delayed-Release Capsules from the affected lot contain N-nitroso-duloxetine impurity at levels exceeding the FDA's recommended interim limit.
A total of 20,734 bottles (30-count bottles) have been distributed nationwide in the United States. The affected lot can be identified by the lot number and expiration date shown on the packaging.
The recalled product
- Product
- 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
- Manufacturer
- Amerisource Health Services LLC
- Category
- Drug
- Hazard
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 DT6023061B Exp 01/31/2025
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 4 recalled by Amerisource Health Services LLC under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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