The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0105-2025·Announced 2024-12-11

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.

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 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
Affected units
209,376

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.

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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