The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0216-2026·Announced 2025-12-10

Duloxetine delayed-release capsules recalled over a nitrosamine impurity above FDA limits

Breckenridge Pharmaceutical is recalling 7,389 bottles of Duloxetine Delayed-Release Capsules, 60 mg, over the presence of N-nitroso-duloxetine above the FDA recommended 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: Scored 3 under the risk-of-harm criterion: an impurity present above the FDA recommended limit is a stated product defect, and no injuries are reported.

Plain-English summary

Duloxetine Delayed-Release Capsules, USP, 60 mg, in 1000-capsule bottles, are being recalled. The prescription product is manufactured by Towa Pharmaceuticals Europe, S.L. in Marotrelles, Barcelona, Spain, and distributed by Breckenridge Pharmaceutical Inc. of Berkeley Heights, New Jersey.

The recall follows current good manufacturing practice deviations and the presence of N-nitroso-duloxetine impurity above the FDA recommended limit.

The recall covers 7,389 bottles from lots 240534C, expiry 01/2027, and 240977C, expiry 04/2027. Distribution was nationwide within the United States. The FDA has classified the action as Class II.

Patients should not stop taking a prescribed medicine without speaking to their prescriber or pharmacist, who can confirm whether a specific bottle is affected and arrange a replacement.

The recalled product

Product
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Brand
DULOXETINE
Manufacturer
Breckenridge Pharmaceutical, Inc.
Category
Drug — Antidepressant
Hazard
Affected units
7,389

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 #: 240534C
  • Exp. Date 01/2027
  • 240977C
  • 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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