← FDA ENFORCEMENT
D-0189-2025Class II

Rising Pharma Holding, Inc.

Recalling firm
Rising Pharma Holding, Inc.
Product type
Drug
Status
Ongoing
Report date
2025-01-15
Distribution
Nationwide
Firm state
NJ
Product quantity
73,680 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 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ NDC 57237-017-60

Code / lot info

Lot # DT2023003A, DT2023007A, DT2023008A, exp. date Jan-25

Other recalls SPEQ maps to Validation & Qualification
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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.