The Recall Desk
HighFDA (Drugs)·D-0190-2025·Announced 2025-01-15

Duloxetine Drug Recall Due to Manufacturing Impurity Levels

Rising Pharma recalls Duloxetine DR Capsules 60 mg nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA limits. Affected batches were distributed nationwide; check lot numbers on bottle labels for affected product.

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 a Class II FDA drug recall for a manufacturing impurity above recommended limits with no reported illnesses or injuries. Per the rubric, it qualifies as High severity—a risk-of-harm product where injury has not yet been reported—but does not meet the Severe threshold, which requires hospitalization reports.

Plain-English summary

Rising Pharma Holding, Inc. is recalling Duloxetine DR Capsules USP 60 mg in both 30-count and 1,000-count bottles due to Current Good Manufacturing Practice (CGMP) deviations and the presence of N-nitroso-duloxetine impurity above FDA-recommended interim limits. Approximately 244,460 bottles have been distributed nationwide.

No illnesses or injuries related to this recall have been reported. However, the presence of the nitrosamine impurity above the recommended level poses a potential risk.

Consumers who have purchased affected bottles should check the lot number on their bottle label against the FDA's detailed recall information. Do not stop taking this medication without consulting your healthcare provider. Contact your pharmacist or healthcare provider for guidance on obtaining an unaffected replacement and for instructions on returning recalled medication.

The recalled product

Product
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Manufacturer
Rising Pharma Holding, Inc.
Category
Drug — Pharmaceutical / Impurity
Hazard
Affected units
244,460

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 (15)

  • Lot # a) DT6023053A
  • DT6023061A
  • DT6023068A
  • DT6023074A
  • exp. date Jan-25
  • DT6023078A
  • DT6023076A
  • exp. date Feb-25
  • DTC24043A
  • DTC24044A
  • exp. date Dec-25 b) DT6023002A
  • DT6023016A
  • DT6023036A
  • exp. date Dec-24
  • DT6023048A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Rising Pharma Holding, Inc. 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.

See all 3 products in this recall →

Related recalls

Same manufacturer · Rising Pharma Holding, Inc.

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Same hazard · n nitroso impurity

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