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

FDA recall notice · announced January 15, 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, 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

Reason for recall

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

Notes

Distribution: Nationwide
Lot/code information: a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25
Quantity: 42,527 bottles
Status: Ongoing
Products in this recall event:
- Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ (D-0190-2025)
- Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60 (D-0189-2025)
- 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 (D-0188-2025)

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