Rising Pharma Holding recalls
FDA enforcement reports naming Rising Pharma Holding, Inc. as the recalling firm.
- Recall reports
- 13
- Class I (serious)
- 0
- Most recent report
- Jul 29, 2026
- Jul 29, 2026Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manuf…Drug · Rising Pharma Holding, Inc.Presence of Precipitate: medication was crystallizing and particles floating in the bottleClass II
- Mar 11, 2026Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manu…Drug · Rising Pharma Holding, Inc.Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testingClass II
- Oct 22, 2025Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only…Drug · Rising Pharma Holding, Inc.Product mix up: complaint received that sealed medication bottle contained Carbidopa, Levodopa, and Entacapone film-coated tablets (37.5 mg/150 mg/200 mg) instead of labelled lower strength Carbidopa, Levodopa, and Ent…Class II
- Mar 26, 2025Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distribut…Drug · Rising Pharma Holding, Inc.CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.Class II
- Jan 15, 2025Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed b…Drug · Rising Pharma Holding, Inc.CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.Class II
- Jan 15, 2025Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 10…Drug · Rising Pharma Holding, Inc.CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.Class II
- Jan 15, 2025Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (ND…Drug · Rising Pharma Holding, Inc.CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.Class II
- Dec 11, 2024Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237…Drug · Rising Pharma Holding, Inc.CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limitClass II
- Dec 11, 2024Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 c…Drug · Rising Pharma Holding, Inc.CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limitClass II
- Dec 11, 2024Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed…Drug · Rising Pharma Holding, Inc.CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limitClass II
- Diflorasone Diacetate Ointment, USP, 0
- Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma H…
- buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx…
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