Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
Product 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.
Lot numbers, UPCs & expiration codes
Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.
Where it was sold
U.S. Nationwide
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0617-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Jun 22, 2026
- FDA report date
- Jul 1, 2026
- Quantity
- 263 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Direct Rx
Original FDA data
Every field from FDA enforcement report D-0617-2026, exactly as published.
Show all FDA fields
- City
- Dawsonville
- State
- GA
- Status
- Ongoing
- Country
- United States
- Event ID
- 99269
- Address
- 94 Worldwide Dr
- Code information
- Lot: a) 09JA2530, 31JA2507, expires: 04/30/2027; b) Lot: 09DE2412, 09JA2528, 29JA2511, expires: 04/30/2027.
- Postal code
- 30534-6828
- Report date
- Jul 1, 2026
- Product type
- Drugs
- Recall number
- D-0617-2026
- Classification
- Class II
- Recalling firm
- Direct Rx
- Product quantity
- 263 Bottles
- Reason for recall
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product 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.
- Distribution pattern
- U.S. Nationwide
- Recall initiation date
- Jun 22, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 23, 2026