The Recall Desk
HighFDA (Drugs)·D-0580-2025·Announced 2025-08-20

Quallent duloxetine 60 mg capsules exceed the interim nitrosamine limit

Duloxetine Delayed-Release Capsules USP 60 mg for Quallent Pharmaceuticals are being recalled because N-nitroso-duloxetine was present above the FDA recommended interim limit. 1,856 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: Risk-of-harm product: a nitrosamine impurity measured above the FDA's named interim limit, with no injury reported in the source.

Plain-English summary

Duloxetine Delayed-Release Capsules, USP, 60 mg, 1,000 capsules per bottle, prescription only, manufactured by Towa Pharmaceutical Europe, S.L. of Martorelles, Barcelona, Spain for Quallent Pharmaceuticals Health LLC, is being recalled. The action covers 1,856 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 240539C, expiring 1/31/2027. Distribution was to New Jersey, Arizona and Indiana.

Patients holding the affected lot should speak to their pharmacist or prescriber before stopping treatment, and pharmacies should follow the instructions issued by the manufacturer.

The recalled product

Product
DULOXETINE (DULOXETINE HYDROCHLORIDE)
Brand
DULOXETINE
Manufacturer
Breckenridge Pharmaceutical, Inc.
Category
Drug — Delayed-release capsule
Hazard
  • nitrosamine
  • n-nitroso-duloxetine
  • impurity-limit
  • cgmp-deviation
  • class-ii

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 240539C
  • Exp 1/31/2027

Distribution

Distributed in 3 states:

  • AZ
  • IN
  • NJ

Related recalls

Same brand · DULOXETINE

Same category