The Recall Desk
HighFDA (Drugs)·D-0101-2025·Announced 2024-12-11

Duloxetine Capsules recalled for manufacturing impurity exceeding FDA interim limit

Amerisource Health Services LLC is recalling 8,561 bottles of Duloxetine Delayed-Release Capsules, 60 mg due to N-nitroso-duloxetine impurity above recommended interim limits. The affected lots were distributed in Pennsylvania, Ohio, and Puerto Rico.

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 recall is classified as High per FDA Class II designation combined with the risk-of-harm nature of N-nitroso impurity in a pharmaceutical product. No illnesses or injuries have been reported, placing this within the 'risk-of-harm products where injury has not yet been reported' category.

Plain-English summary

Amerisource Health Services LLC is recalling 8,561 bottles of Duloxetine Delayed-Release Capsules, USP, 60 mg (NDC 68001-415-08), manufactured by Aurobindo Pharma Limited and distributed for BluePoint Laboratories. The recall affects multiple lot numbers with expiration dates ranging from November 30, 2024, through February 28, 2025.

The recall is due to current Good Manufacturing Practice (cGMP) deviations identified in the manufacturing process. The deviation involves the presence of N-nitroso-duloxetine impurity at levels exceeding the FDA's recommended interim limit.

The affected capsules were distributed in Pennsylvania, Ohio, and Puerto Rico. Patients and healthcare providers in these areas with recalled product should consult with their pharmacy regarding the affected lot numbers and whether they may have received recalled medication.

The recalled product

Product
Duloxetine Delayed-Release Capsules, USP, 60 mg, Rx only, 1,000 count bottle, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories NDC 68001-415-08
Manufacturer
Amerisource Health Services LLC
Category
Drug — Antidepressant
Hazard
  • n-nitroso-impurity
  • manufacturing-defect

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
  • expiry: DT6022159A
  • DT6022167A
  • DT6022168A
  • exp 11/30/2024
  • Lot DT6023034A
  • 12/31/2024
  • Lots DT6023050A
  • DT6023051A
  • DT6023063A
  • DT6023067A
  • exp 01/31/2025
  • Lots DT6023073A
  • DT6023072A
  • exp 02/28/2025

Distribution

Distributed in 3 states:

  • OH
  • PA
  • PR

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