← FDA ENFORCEMENT
D-0106-2025Class II

Rising Pharma Holding, Inc.

Recalling firm
Rising Pharma Holding, Inc.
Product type
Drug
Status
Ongoing
Report date
2024-12-11
Distribution
Nationwide.
Firm state
NJ
Product quantity
122,925 bottles
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Validation & Qualification
Reason for recall

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

Product description

Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 1000 count (NDC 57237-018-99) bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ

Code / lot info

a) 30s; DT3023019A, exp. date Jan-25 DT3023050A, exp. date Apr-25; b) 90s; DT3023022A, exp. date Jan-25; c) 1000s; DT3022108A, DT3022107A, DT3022106A, DT3022111A, DT3022109A, exp. date Nov-24, DT3023001A, DT3023003A, exp. date Dec-24, DT3023024A, DT3023020B, exp. date Jan-25 DT3023027A, DT3023028A, exp. date Feb-25, DT3023034A, exp. date Mar-25, DT3023049A, exp. date Apr-25, DT3023095A, exp. date Jul-25

Other recalls SPEQ maps to Validation & Qualification
2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc2026-07-22Class IIBell Pharmaceuticals, Inc
See all Validation & Qualification recalls →

Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.