The Recall Desk
HighFDA (Drugs)·D-0567-2025·Announced 2025-08-13

Duloxetine delayed-release capsules exceed the interim nitrosamine impurity limit

Duloxetine Delayed-Release 20 mg capsules packaged by Direct Rx are being recalled because a nitrosamine drug substance related impurity was present above the proposed interim limit. 16 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 named interim limit, with no injury reported in the source.

Plain-English summary

Duloxetine D/R, 20 mg, 30 capsules per bottle, prescription only, packaged and distributed by Direct Rx and distributed by Breckenridge Pharmaceuticals, Inc. of Berlin, Connecticut, NDC 61919-422-30, is being recalled. The action covers 16 bottles.

The stated reason is CGMP deviations: the presence of a nitrosamine drug substance related impurity above the proposed interim limit. The FDA classified the action as Class II.

The affected lot is 02AU2406, expiring 01/31/2027. Distribution was nationwide.

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

The recalled product

Product
Duloxetine D/R, 20 mg, 30 Caps, 30-count bottle, RX Only, Packaged & Distributed by: Direct Rx, Dist. By Breckenridge Pharm., Inc., Berlin, CT 06037, NDC 61919-422-30
Manufacturer
Direct Rx
Category
Drug — Delayed-release capsule
Hazard
  • nitrosamine
  • 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 #: 02AU2406
  • Exp 01/31/2027

Distribution

Distributed nationwide across the United States.

Related recalls

Same category