Rising Pharma Holding, Inc.

FDA Regulatory Profile

Summary

Total Recalls
12
510(k) Clearances
0
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
D-0384-2026Class IIProduct label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for:March 3, 2026
D-0029-2026Class IICarbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, ManufactureOctober 7, 2025
D-0277-2025Class IIDuloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: RisingMarch 5, 2025
D-0190-2025Class IIDuloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-9December 30, 2024
D-0188-2025Class IIDuloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDCDecember 30, 2024
D-0189-2025Class IIDuloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising PhaDecember 30, 2024
D-0105-2025Class IIDuloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising PhNovember 19, 2024
D-0107-2025Class IIDuloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and cNovember 19, 2024
D-0106-2025Class IIDuloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 572November 19, 2024
D-0599-2024Class IIIDiflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., BroJune 24, 2024
D-0541-2024Class IIIPregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc.May 16, 2024
D-0222-2024Class IIbuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, ManufacDecember 29, 2023