The Recall Desk
ModerateFDA (Drugs)·D-0387-2025·Announced 2025-04-30

Duloxetine delayed-release capsules recalled for nitrosamine impurity

Breckenridge Pharmaceutical is recalling Duloxetine 60 mg delayed-release capsules nationwide due to elevated levels of a nitrosamine-related impurity that exceed the FDA's interim safety limit. The affected lots include bottles with expiration dates in April 2027.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II with a manufacturing deviation (CGMP violation) resulting in an impurity above the interim limit. The source text does not report any illnesses or hospitalizations, making this a precautionary recall rather than one with documented adverse health outcomes.

Plain-English summary

Breckenridge Pharmaceutical, Inc. is recalling Duloxetine (duloxetine hydrochloride) delayed-release capsules, 60 mg, in 1000-count bottles distributed nationwide. The recall affects 16,473 bottles in two lots: #240987C and #241014C, both with expiration dates of April 2027. The NDC number is 51991-748-10.

The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation. Testing identified a nitrosamine drug substance-related impurity present at levels above the FDA's proposed interim limit in the affected lots.

Patients taking this medication should consult their healthcare provider before making any changes to their treatment. Consumers who have purchased affected bottles should stop using them and contact their pharmacy or healthcare provider for guidance. The recalling firm is Breckenridge Pharmaceutical, Inc., located in Berkeley Heights, New Jersey. The product was manufactured by Towa Pharmaceutical Europe, S.L.

The recalled product

Product
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Brand
DULOXETINE
Manufacturer
Breckenridge Pharmaceutical, Inc
Category
Drug — Antidepressant / Serotonin-Norepinephrine Reuptake Inhibitor
Hazard
Affected units
16,473

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 (3)

  • Lot # 240987C
  • exp. date 04/2027 241014C
  • exp. date 04/2027

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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Same hazard · nitrosamine impurity

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