FDAClass II · Drug · Recalled July 1, 2026

DULOXETINE D/R recall — Direct Rx

Hazard: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID: D-0617-2026
Brand: Direct Rx
Classification: Class II
Units affected: 263 Bottles
Recall status: Ongoing
Initiated: Voluntary: Firm initiated

Description

DULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.

Affected products

DULOXETINE D/R

Companies & origin

Recalling firm location: Dawsonville, GA, United States
Firm address: 94 Worldwide Dr, N/A, 30534-6828

Identifying details (verbatim from the notice)

Product codes / lots: Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.
Distribution: U.S. Nationwide
Firm notified the public via: Letter
FDA event ID: 99269
Recall initiated: June 22, 2026
FDA classified: June 23, 2026
FDA report date: July 1, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 24, 2026 at 12:00 AM UTC.

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