The Recall Desk
HighFDA (Drugs)·D-0165-2025·Announced 2025-01-01

Duloxetine delayed-release capsules recalled due to manufacturing impurity

Duloxetine delayed-release 60mg capsules are being recalled nationwide due to N-nitroso-duloxetine impurity above recommended interim limits. Two lot numbers are affected: J0786744-061724 (blister cards) and B3002625-060524 (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: FDA Class II recall with no reported illnesses or injuries. This is a pharmaceutical quality issue involving an impurity above recommended limits, representing a risk-of-harm situation without documented adverse effects, consistent with the High severity category per the rubric.

Plain-English summary

Duloxetine delayed-release capsules, 60 mg, are being recalled by RemedyRepack Inc., a pharmaceutical repackager located in Indiana, Pennsylvania. Two packaging configurations are affected: blister cards (NDC 70518-0937-04, lot J0786744-061724) and bottles (NDC 70518-0937-03, lot B3002625-060524). Approximately 1,564 blister cards and 799 bottles are included in this recall. The product was distributed nationwide across the United States.

The recall was initiated due to current good manufacturing practice (CGMP) deviations. The affected lots contain N-nitroso-duloxetine, a chemical impurity, at concentrations exceeding the recommended interim limit. This impurity was identified during quality assurance testing.

Patients taking Duloxetine from the affected lot numbers should contact their pharmacy or healthcare provider immediately. You can verify whether your medication is affected by checking the NDC and lot number on your bottle or blister card packaging against those listed above.

The recalled product

Product
Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70518-0937-04), b) 30 count bottles (NDC 70518-0937-03), Rx only, Source NDC 57237-0019-99, MFG: Rising Pharma, Inc., Allendale, NJ, Repackaged by: RemedyRepack Inc., Indiana, PA
Manufacturer
RemedyRepack 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 (5)

  • a) NDC 70518-0937-04
  • Lot # J0786744-061724
  • Exp. 06/30/2025 b) NDC 70518-0937-03
  • Lot # B3002625-060524
  • Exp. 10/31/2025

Distribution

Distributed nationwide across the United States.

Related recalls

Same category