The Recall Desk
ModerateFDA (Drugs)·D-0388-2025·Announced 2025-04-30

Duloxetine Delayed-Release Capsules Recalled for Nitrosamine Impurity

Breckenridge Pharmaceutical is recalling Duloxetine Delayed-Release Capsules 30 mg nationwide due to the presence of a nitrosamine drug substance related impurity above proposed interim limits.

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: This is an FDA Class II recall without any reported illnesses or injuries. The hazard is a manufacturing impurity (nitrosamine) detected above interim limits, which represents a precautionary recall due to process deviations rather than immediate confirmed harm.

Plain-English summary

Breckenridge Pharmaceutical, Inc. is recalling Duloxetine Delayed-Release Capsules USP, 30 mg (distributed nationwide) because testing identified a nitrosamine drug substance related impurity present above the proposed interim limit. The recalled product includes 90-count bottles (NDC# 51991-747-90) and 1000-count bottles (NDC 51991-747-10) manufactured by Towa Pharmaceutical Europe, S.L. Three specific lot numbers are affected: #230201C, #230471C, and #230288C, all with expiration date 01/2026.

This is a Class II recall by the FDA. Patients currently taking this medication should not stop taking it without consulting their healthcare provider. Consumers with affected product should contact their pharmacist or healthcare provider for guidance on alternatives or next steps. More information is available from FDA at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls or by contacting Breckenridge Pharmaceutical, Inc.

The recalled product

Product
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Brand
DULOXETINE
Manufacturer
Breckenridge Pharmaceutical, Inc
Category
Drug — Oral Prescription
Hazard
Affected units
343,344

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 (4)

  • Lot # 230201C
  • exp. date 01/2026 230471C
  • exp. date 01/2026 230288C
  • exp. date 01/2026

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 →

Related recalls

Same brand · DULOXETINE

Same manufacturer · Breckenridge Pharmaceutical, Inc

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Same hazard · nitrosamine impurity

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