FDA Drugs recall ·
DULOXETINE D/R, a) 30 mg ( recall
- Recall number
- D-0617-2026
- Date
- (initiated June 22, 2026)
- Company / brand
- Direct Rx
94 Worldwide Dr, Dawsonville, GA, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 263 Bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.
Distribution
U.S. Nationwide
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0617-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.