Duloxetine Delayed-Release Capsules Nationwide Recall for N-Nitroso Impurity
Rising Pharma recalls Duloxetine Delayed-Release Capsules 20 mg nationwide due to N-nitroso-duloxetine impurity exceeding recommended interim limits, affecting 209,376 bottles.
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 FDA Class II recall involves a recognized hazardous impurity (N-nitroso compounds) detected above regulatory limits, fitting the criterion 'risk-of-harm products where injury has not yet been reported.' Though no illnesses or injuries are currently reported, N-nitroso impurities are documented manufacturing concerns warranting the High severity level.
Plain-English summary
Duloxetine Delayed-Release Capsules USP, 20 mg, are being recalled nationwide by Rising Pharma Holdings, Inc., because of the presence of N-nitroso-duloxetine impurity above recommended interim limits. The recall covers approximately 209,376 bottles distributed across the United States.
The impurity was identified through Current Good Manufacturing Practice (CGMP) compliance monitoring. To date, no patient illnesses or injuries have been reported in connection with this recall.
The affected lots include: DT2022023A, DT2022024A, DT2022025A, DT2022026A, and DT2022027A (expiring November 2024); and DT2023001B, DT2023004A, DT2023005A, and DT2023006A (expiring January 2025). The product is Rx-only and distributed by Rising Pharma Holdings, Inc., of East Brunswick, New Jersey.
The recalled product
- Product
- Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ NDC 57237-017-60
- Manufacturer
- Rising Pharma Holding, Inc.
- Category
- Drug
- Hazard
- n-nitroso-impurity
- cgmp-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 (10)
- a) Lot # DT2022023A
- DT2022024A
- DT2022025A
- DT2022026A
- DT2022027A
- exp. date Nov-24 DT2023001B
- DT2023004A
- DT2023005A
- DT2023006A
- exp. date Jan-25
Distribution
Distributed nationwide across the United States.
Related recalls
Same category
- CriticalWarfarin Tablets Recalled After Mix-Up Between 2.5 mg and 5 mg Strengths
FDA (Drugs) · 2026-07-21
- ModerateFDA Recalls Pred Mild Ophthalmic Suspension Due to Failed Stability Specifications
FDA (Drugs) · 2026-06-03
- ModerateNicotine Transdermal System Patches Recalled for Oxidative Impurity Specification Failure
FDA (Drugs) · 2026-06-03
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- HighLiraglutide Injection Recalled Due to Particulate Matter in Cartridges
FDA (Drugs) · 2026-05-27