FDA Drugs recall ·
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count ( recall
- Recall number
- D-0188-2025
- Date
- (initiated December 30, 2024)
- Company / brand
- Rising Pharma Holding, Inc.
2 Tower Center Blvd Ste 1401, East Brunswick, NJ, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 42,527 bottles
- Hazard tags
- Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ
Why was it recalled?
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above 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
a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25
Distribution
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-0188-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.