The Recall Desk
HighFDA (Drugs)·D-0100-2025·Announced 2024-12-11

Duloxetine Delayed-Release Capsules Recalled Due to N-nitroso Impurity

Amerisource Health Services is recalling specific lots of Duloxetine 30 mg capsules due to N-nitroso-duloxetine impurity levels exceeding FDA recommendations. Patients taking affected lots should contact their healthcare provider immediately.

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 pharmaceutical recall initiated due to CGMP deviations and N-nitroso impurity levels exceeding interim limits. Although no illnesses or hospitalizations have been reported, this represents a risk-of-harm situation for a prescription medication where regulatory action was taken to prevent potential future harm.

Plain-English summary

Amerisource Health Services LLC is recalling specific lots of Duloxetine Delayed-Release Capsules, USP, 30 mg, a prescription antidepressant medication, due to Current Good Manufacturing Practice (CGMP) deviations. The recall was initiated because N-nitroso-duloxetine impurity was detected in certain manufactured lots at levels exceeding the FDA's recommended interim limit.

The recall affects 23,490 bottles across two package sizes: 30-count bottles (NDC 68001-414-04) and 1,000-count bottles (NDC 68001-414-08). The affected lots are DT3023019B and DT3023020A (30-count, expiring 01/31/2025) and DTB23098A (1,000-count, expiring 08/31/2025). The product was manufactured by Aurobindo Pharma Limited in India and distributed in Pennsylvania, Ohio, and Puerto Rico.

Patients currently taking this medication should not stop without consulting their healthcare provider. If you have received one of the affected lots, contact your pharmacy or healthcare provider immediately for guidance on next steps.

The recalled product

Product
Duloxetine Delayed-Release Capsules, USP, 30 mg, Rx only, a) 30 count (NDC 68001-414-04) and b) 1,000 count (NDC 68001-414-08) bottles, Manufactured by: Aurobindo Pharma Limited, Hyderabad-500 090, India, For BluePoint Laboratories
Manufacturer
Amerisource Health Services LLC
Category
Drug
Hazard
  • n-nitroso-impurity

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 (7)

  • a) 30 count
  • Lot
  • expiry: DT3023019B
  • DT3023020A
  • exp 01/31/2025 b) 1000 count
  • expiry: DTB23098A
  • exp 08/31/2025

Distribution

Distributed in 3 states:

  • OH
  • PA
  • PR

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