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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
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 23, 2026 at 11:04 PM UTC.
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