The Recall Desk
HighFDA (Drugs)·D-0106-2025·Announced 2024-12-11

Duloxetine Delayed-Release Capsules Recalled for N-Nitroso Impurity Above Limits

Rising Pharma is recalling 122,925 bottles of Duloxetine 30 mg capsules nationwide due to a manufacturing deviation: the presence of N-nitroso-duloxetine impurity above the 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: This Class II recall involves a known-concern impurity (N-nitroso-duloxetine) above its recommended interim limit due to manufacturing deviation. Although no illnesses or injuries have been reported, this represents a risk-of-harm scenario, satisfying the High severity rubric criterion.

Plain-English summary

Rising Pharma Holdings, Inc. is recalling Duloxetine Delayed-Release Capsules USP, 30 mg in 30-count, 90-count, and 1000-count bottles distributed nationwide. The recall encompasses 122,925 bottles across product batches with NDC numbers 57237-018-30, 57237-018-90, and 57237-018-99.

The FDA issued this Class II recall due to a Current Good Manufacturing Practice (CGMP) deviation: the presence of N-nitroso-duloxetine impurity in the product above the recommended interim limit.

Patients taking this medication should consult with their healthcare provider or pharmacist for guidance regarding their treatment. No illnesses or injuries have been reported in connection with this recall.

The recalled product

Product
Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ
Manufacturer
Rising Pharma Holding, Inc.
Category
Drug — Antidepressant
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 (20)

  • a) 30s
  • DT3023019A
  • exp. date Jan-25 DT3023050A
  • exp. date Apr-25
  • b) 90s
  • DT3023022A
  • exp. date Jan-25
  • c) 1000s
  • DT3022108A
  • DT3022107A
  • DT3022106A
  • DT3022111A
  • DT3022109A
  • exp. date Nov-24
  • DT3023001A
  • DT3023003A
  • exp. date Dec-24
  • DT3023024A
  • DT3023020B
  • exp. date Jan-25 DT3023027A

Distribution

Distributed nationwide across the United States.

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