The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0582-2026·Announced 2026-06-17

Duloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit

Duloxetine Delayed-Release Capsules, USP, 30 mg, in 1,000-capsule bottles are being recalled because of N-nitroso-duloxetine impurity above the FDA recommended interim limit.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

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, 30 mg, 1,000-capsule bottles, prescription only, manufactured by Towa Pharmaceutical Europe, S.L. of Martorelles, Barcelona, Spain and distributed by Breckenridge Pharmaceuticals, Inc. of Berkeley Heights, New Jersey, are being recalled. The action covers 14,729 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.

The affected lot is 241180C, expiring April 2027. Distribution was nationwide within the United States.

Patients should not stop taking a prescribed medicine without advice. Anyone holding the 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
14,729

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: 241180C
  • 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 →

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