Rising Pharma Holding recalls
Rising Pharma Holding appears in 13 official U.S. recall notices indexed by RecallRadar, most recently on 2026-07-29.
Company names are normalized from agency data (legal suffixes removed), so related firms may appear under separate pages.
Recall summary
| Recall notices | 13 |
|---|---|
| Published | 2024-01-17 to 2026-07-29 |
| By agency | FDA Drug (13) |
| By classification | Class II (11), Class III (2) |
| By status | ongoing (13) |
| Distribution named in notices | US |
Recalls
- Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc., East Brun…
FDA Drug · Class II · 2026-07-29 · Rising Pharma Holding
Reason: Presence of Precipitate: medication was crystallizing and particles floating in the bottle - Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc., Allendal…
FDA Drug · Class II · 2026-03-11 · Rising Pharma Holding
Reason: Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing - Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc
FDA Drug · Class II · 2025-10-22 · Rising Pharma Holding
Reason: 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 Enta… - Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, N…
FDA Drug · Class II · 2025-03-26 · Rising Pharma Holding
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit. - Duloxetine DR Capsules USP 60 mg, a) 30 count (NDC 57237-019-30) and b) 1000 count (NDC 57237-019-99) bottles
FDA Drug · Class II · 2025-01-15 · Rising Pharma Holding
Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. - Duloxetine Delayed-Release Capsules USP 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharm Holdings, Inc., East Brunswick, NJ N…
FDA Drug · Class II · 2025-01-15 · Rising Pharma Holding
Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. - Duloxetine Delayed-Release Capsules USP 30 mg, a) 30 count (NDC 57237-018-30) and b) 1000 count (NDC 57237-018-99) bottles, Rx only, Distri…
FDA Drug · Class II · 2025-01-15 · Rising Pharma Holding
Reason: CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit. - 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 57237-019-99) bottles…
FDA Drug · Class II · 2024-12-11 · Rising Pharma Holding
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit - Duloxetine Delayed-Release Capsules USP, 20 mg, 60 count bottles, Rx only, Distributed by: Rising Pharma Holdings, Inc., East Brunswick, NJ…
FDA Drug · Class II · 2024-12-11 · Rising Pharma Holding
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit - 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…
FDA Drug · Class II · 2024-12-11 · Rising Pharma Holding
Reason: CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit - Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd
FDA Drug · Class III · 2024-07-17 · Rising Pharma Holding
Reason: Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit. - Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816, Manufacture…
FDA Drug · Class III · 2024-06-12 · Rising Pharma Holding
Reason: Presence of Foreign Tablets/Capsules: Complaint received from a re-packager, American Health Packaging (AHP), where a foreign tablet was discovered in one of the bottles during packaging set up. Tablet identified as pan… - buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma Holdings, Inc
FDA Drug · Class II · 2024-01-17 · Rising Pharma Holding
Reason: Presence of Foreign Tablets/Capsules