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

FDA recall notice · announced March 26, 2025 · Rising Pharma Holding

Class II FDA/FSIS Class II: use may cause temporary or medically reversible adverse health consequences.

The product

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

Reason for recall

CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.

Notes

Distribution: Nationwide in the USA.
Lot/code information: Lot #: DTB23111A, Exp 8/31/2025
Quantity: 1223 bottles
Status: Ongoing
Products in this recall event:
- 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 (D-0277-2025)

Source: U.S. Food and Drug Administration public recall data. This page reports official records and is not legal, medical, or repair advice.