The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0107-2025·Announced 2024-12-11

Duloxetine DR Capsules recalled nationwide for nitrosamine impurity

Rising Pharmaceuticals is recalling Duloxetine DR Capsules 60 mg nationwide due to N-nitroso-duloxetine impurity levels exceeding FDA interim limits. The recall affects approximately 233,003 bottles.

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: This is an FDA Class II recall for N-nitroso-duloxetine impurity above recommended interim limits. No illnesses, injuries, or hospitalizations have been reported. The presence of the impurity above FDA-recommended interim limits indicates risk-of-harm; per the rubric, risk-of-harm products where injury has not yet been reported are scored as High (3).

Plain-English summary

Rising Pharmaceuticals, Inc. is recalling Duloxetine DR Capsules USP 60 mg nationwide. The recall affects approximately 233,003 bottles in three package sizes: 30-count (NDC 57237-019-30), 90-count (NDC 57237-019-90), and 1,000-count (NDC 57237-019-99) bottles.

The recall was initiated due to manufacturing deviations and the presence of N-nitroso-duloxetine impurity above the FDA's recommended interim limit. The FDA has classified this as a Class II recall.

Patients currently taking the affected medication should contact their healthcare provider or pharmacist to confirm whether their medication is included in the recall. Affected lot numbers and expiration dates are documented by the FDA. Healthcare providers can advise on next steps based on individual patient circumstances.

The recalled product

Product
Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57237-019-99) bottles, Distributed by: Rising Pharmaceuticals, Inc., East Brunswick, NJ
Manufacturer
Rising Pharma Holding, Inc.
Category
Drug
Hazard
Affected units
233,003

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
  • DT6023059A
  • DT6023060A
  • DT6023065A
  • DT6023069A
  • DT6023070A
  • exp. date Jan-25
  • DT6023080A
  • exp. date Feb-25
  • DT6023093A
  • exp. date Mar-25
  • DTC24012A
  • exp. date Dec-25
  • b) 90s
  • DT6023108A
  • exp. date Apr-25
  • DTC23201A
  • exp. date Aug-25
  • c) 1000s
  • DT6022160A

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 →

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