The Recall Desk
HighFDA (Drugs)·D-0583-2026·Announced 2026-06-17

Duloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit

Duloxetine Delayed-Release Capsules, USP, 60 mg, are being recalled because of N-nitroso-duloxetine impurity above the FDA recommended interim limit. 359,676 bottles affected.

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 recall where a nitrosamine impurity exceeds the FDA interim limit, a risk of harm with no injuries reported in the source.

Plain-English summary

Duloxetine Delayed-Release Capsules, USP, 60 mg, in 90-capsule bottles (NDC 51991-748-90) and 1,000-capsule bottles (NDC 51991-748-10), prescription only, manufactured by Towa Pharmaceutical Europe, S.L. of Martorelles, Barcelona, Spain and distributed by Breckenridge Pharmaceutical, are being recalled. The action covers 359,676 bottles.

The stated reason is CGMP deviations: the presence of N-nitroso-duloxetine impurity above the FDA recommended interim limit. The FDA classified the action as Class II.

Affected lots are listed in the recall notice, including 241074C expiring May 2027. Distribution was nationwide within the United States.

Patients should not stop taking a prescribed medicine without advice. Anyone holding an affected lot should speak to their pharmacist or prescriber and follow the instructions issued by the firm.

The recalled product

Product
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Brand
DULOXETINE
Manufacturer
Breckenridge Pharmaceutical, Inc.
Category
Drug — Antidepressant capsule
Hazard
Affected units
359,676

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 (17)

  • Lot: a) 241074C
  • Exp. Date May 2027
  • 240317
  • 240318
  • 240315C
  • 240373C
  • 240370C
  • 240375C
  • 240413C
  • Exp. Date February 2027
  • 240316
  • Exp. Date January 2027
  • 232311
  • Exp. Date November 2026
  • b) 240978C
  • 241052C
  • Exp. Date April 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 →

Related recalls

Same brand · DULOXETINE

Same manufacturer · Breckenridge Pharmaceutical, Inc.

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Same hazard · nitrosamine

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