Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Product description
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
Lot numbers, UPCs & expiration codes
Lot #: DTB23111A, Exp 8/31/2025
Where it was sold
Nationwide in the USA.
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-0277-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Mar 5, 2025
- FDA report date
- Mar 26, 2025
- Quantity
- 1223 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Rising Pharma Holding, Inc.
Original FDA data
Every field from FDA enforcement report D-0277-2025, exactly as published.
Show all FDA fields
- City
- East Brunswick
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 96427
- Address
- 2 Tower Center Blvd Ste 1401
- Code information
- Lot #: DTB23111A, Exp 8/31/2025
- Postal code
- 08816-1149
- Report date
- Mar 26, 2025
- Product type
- Drugs
- Recall number
- D-0277-2025
- Classification
- Class II
- Recalling firm
- Rising Pharma Holding, Inc.
- Product quantity
- 1223 bottles
- Reason for recall
- CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
- Distribution pattern
- Nationwide in the USA.
- Recall initiation date
- Mar 5, 2025
- Initial firm notification
- Letter
- Center classification date
- Mar 14, 2025