The Recall Desk
HighFDA (Drugs)·D-0162-2025·Announced 2025-01-01

Duloxetine antidepressant recall for chemical impurity above FDA limit

Breckenridge Pharmaceutical is recalling Duloxetine 60 mg delayed-release capsules due to N-nitroso-duloxetine impurity above FDA's interim limit. The recall affects 76,968 bottles distributed nationwide.

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 with a chemical impurity of concern (N-nitroso compound). No deaths, injuries, or illnesses have been reported. The hazard represents a risk-of-harm product where injury has not yet been reported, meeting the High severity criterion.

Plain-English summary

Breckenridge Pharmaceutical, Inc. is recalling Duloxetine (duloxetine hydrochloride) delayed-release capsules, 60 mg, in 90-count bottles. The affected lot is #230077C with an expiration date of 11/2025. The product is distributed nationwide in the United States.

The recall was initiated due to a manufacturing defect—specifically, the presence of N-nitroso-duloxetine impurity above the FDA's recommended interim limit. This impurity was identified during current Good Manufacturing Practice (CGMP) testing.

The recall affects 76,968 bottles. Patients who have received this medication should verify their lot number and expiration date.

Consumers should not discontinue their duloxetine medication without consulting their healthcare provider. Patients with bottles from lot #230077C should contact their pharmacy or healthcare provider for guidance on obtaining a replacement supply.

The recalled product

Product
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Brand
DULOXETINE
Manufacturer
Breckenridge Pharmaceutical, Inc
Category
Drug — Antidepressant
Hazard
Affected units
76,968

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 (2)

  • Lot # 230077C
  • exp. date 11/2025

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Breckenridge Pharmaceutical, 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 2 products in this recall →

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