FDAHealthJune 22, 2026
Direct Rx — 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.
⚠️ CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- June 22, 2026
U.S. Nationwide
What's affected?
- 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.
- Brand
- Direct Rx
- Lot code
- a)
Additional details
Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 263 Bottles.
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