Home / Recalls / Rising Pharma Holding, Inc. / D-0188-2025

D-0188-2025 Class II Ongoing

Recalled by Rising Pharma Holding, Inc. — East Brunswick, NJ

Recall Details

Product Type
Drugs
Report Date
January 15, 2025
Initiation Date
December 30, 2024
Termination Date
N/A
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
42,527 bottles

Product Description

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.

Distribution Pattern

Nationwide

Code Information

a) Lot# DT3023051A, exp. date Apr-25; b) DT3023025A, exp. date Jan-25

Other recalls by Rising Pharma Holding, Inc.

  • D-0384-2026 Class II — Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx onl (March 3, 2026)
  • D-0029-2026 Class II — Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, (October 7, 2025)
  • D-0277-2025 Class II — Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Di (March 5, 2025)
  • D-0190-2025 Class II — Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 co (December 30, 2024)
  • D-0189-2025 Class II — Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distri (December 30, 2024)
  • D-0105-2025 Class II — Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distr (November 19, 2024)
  • D-0107-2025 Class II — Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count ND (November 19, 2024)
  • D-0106-2025 Class II — Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), (November 19, 2024)
  • D-0599-2024 Class III — Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Lab (June 24, 2024)
  • D-0541-2024 Class III — Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising P (May 16, 2024)