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Rising Pharma Holding, Inc. FDA Recalls
13 recalls on file across drugs, 0 of them Class I and 13 still open. This firm is not matched to a listed company.
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Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma HoldinClass IIJul 13, 2026Presence of Precipitate: medication was crystallizing and pa |
| Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising PharmaceuticClass IIMar 3, 2026Failed Impurities/Degradation Specifications: An out-of-spec |
| Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising PharmaClass IIOct 7, 2025Product mix up: complaint received that sealed medication b |
| Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, SaddleClass IIMar 5, 2025CGMP Deviations: Presence of N-nitroso-duloxetine impurity a |
| Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles; DistribuClass IIDec 30, 2024CGMP Deviations; Presence of N-nitroso-duloxetine impurity a |
| Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottlClass IIDec 30, 2024CGMP Deviations; Presence of N-nitroso-duloxetine impurity a |
| Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., EClass IIDec 30, 2024CGMP Deviations; Presence of N-nitroso-duloxetine impurity a |
| Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30), b) 90 count NDC 57237-019-90 and c) 1000 count (NDC 57Class IINov 19, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a |
| Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc.,Class IINov 19, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a |
| Duloxetine Delayed-Release Capsules USP, 30 mg, a) 30 count (NDC 57237-018-30), b) 90 count (NDC 57237-018-90) and c) 10Class IINov 19, 2024CGMP Deviations: Presence of N-nitroso-duloxetine impurity a |
| Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; MfdClass IIIJun 24, 2024Failed Impurities/Degradation Specifications: The impurity |
| Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJClass IIIMay 16, 2024Presence of Foreign Tablets/Capsules: Complaint received fro |
| buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising PhClass IIDec 29, 2023Presence of Foreign Tablets/Capsules |