Duloxetine Delayed-Release Capsules recalled for manufacturing deviation and impurity
Rising Pharma is recalling certain batches of Duloxetine Delayed-Release Capsules 30 mg due to a manufacturing deviation that resulted in elevated N-nitroso-duloxetine impurity above FDA's recommended interim limit.
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: Although no illnesses or injuries have been reported, N-nitroso compounds are recognized as potential carcinogens. The presence of this impurity above the FDA's recommended interim safety limit in a prescription medication represents a documented risk of harm to patients, meeting the criteria for a High severity rating despite the absence of acute injury reports.
Plain-English summary
Rising Pharma Holding, Inc. is recalling Duloxetine Delayed-Release Capsules USP 30 mg in two package sizes: 30-count bottles (NDC 57237-018-30) and 1000-count bottles (NDC 57237-018-99). A total of 42,527 bottles are affected. The product is a prescription antidepressant and anti-anxiety medication distributed nationwide.
The recall was initiated due to a manufacturing deviation resulting in the presence of N-nitroso-duloxetine impurity above the FDA's recommended interim limit. This represents non-compliance with current Good Manufacturing Practice (CGMP) standards.
The affected batches are identified by lot numbers and expiration dates: Lot# DT3023051A (expiring April 2025) and Lot# DT3023025A (expiring January 2025). Patients who have received Duloxetine from these batches should contact their pharmacy or healthcare provider for guidance regarding their medication.
The recalled product
- Product
- Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
- Manufacturer
- Rising Pharma Holding, Inc.
- Hazard
- n-nitroso-impurity
- manufacturing-deviation
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 (4)
- a) Lot# DT3023051A
- exp. date Apr-25
- b) DT3023025A
- exp. date Jan-25
Distribution
Distributed nationwide across the United States.
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