Reported Mar 26, 2025 · Ongoing
Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC,…
Rising Pharma Holding, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Rising Pharma Holding, Inc. · 2 Tower Center Blvd Ste 1401 · East Brunswick, NJ · 08816-1149
Is this the product you have?
- Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only
- Distributed byRising Health, LLC, Saddle Brook, NJ 07663, NDC 57237-018-99
- Lot codes and dates
Lot #: DTB23111AExp 8/31/2025
- Amount recalled
- 1223 bottles
Where it was sold
- Nationwide
Why it was recalled
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
This product could cause temporary or reversible health problems — stop using it.
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