Rising Pharma Holding, Inc. recalls 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,…
CGMP Deviations; Presence of N-nitroso-duloxetine impurity above recommended interim limit.
Read the official notice →- Date
- 2025-01-15
- Country
- United States
- Brand
- Rising Pharma Holding
- Product
- 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,…
- Classification
- Class II
- Units
- Nationwide
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Rising Pharma Holding recalls
- 2026-03-11
US
Rising Pharma Holding, Inc. recalls Product label: Temozolomide Capsules, 5mg, packaged in 5-capsule bottles, Rx only, Manufactured for: Rising Pharmaceuticals, Inc.,…
Failed Impurities/Degradation Specifications: An out-of-specification result observed during 9th-month long term stability testing
- 2025-10-22
US
Rising Pharma Holding, Inc. recalls Carbidopa, Levodopa, Entacapone Tablets, 25 mg/100 mg/200 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings,…
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…
- 2025-03-26
US
Rising Pharma Holding, Inc. recalls Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit.
- 2024-12-11
US
Rising Pharma Holding, Inc. recalls 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)…
CGMP Deviations: Presence of N-nitroso-duloxetine impurity above recommended interim limit
- 2024-07-17
US
Rising Pharma Holding, Inc. recalls Diflorasone Diacetate Ointment, USP, 0.05%, 60g tube, Rx only, Mfd. By: Lyne Laboratories, Inc., Brockton, MA 02301; Mfd. For: Rising…
Failed Impurities/Degradation Specifications: The impurity results at 12 months stability testing,did not conform to the specification limit.
- 2024-06-12
US
Rising Pharma Holding, Inc. recalls Pregabalin Capsules 50mg, 1000-count bottle, Rx Only, Manufactured for: Rising Pharma Holdings, Inc., East Brunswick, NJ 08816,…
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…
Other drugs & medical recalls in the United States
- 2025-01-15
US
Maquet Cardiovascular, LLC recalls VasoView HemoPro 2 Endoscopic Vessel Harvesting System. Model Numbers: VH-4000. Indicated for use in minimally invasive surgery…
Potential for two issues: 1. Bent or detached heater wire; 2. Silicone peeling or detaching from the Jaws of the Harvesting Tool
FDA · DeviceMaquet Cardiovascular, LLCNationwide distribution. International distribution to Australia, Austria,…Official notice →US
Granules Pharmaceuticals Inc. recalls Metformin Hydrochloride Extended-Release Tablets, USP, 500 mg, 1000-count bottles, Rx Only, Manufactured by: Granules India…
Presence of Foreign Tablets/Capsules: A Paracetamol 500 mg tablet was found in a 1000-count bottle of Metformin HCL ER Tablets USP, 500 mg.
US
US
Granules Pharmaceuticals Inc. recalls Colchicine Capsules 0.6 mg, 30-count bottles, Rx only, Manufactured by: Granules Pharmaceuticals Inc. Chantilly, VA 20151 NDC…
Failed Dissolution Specifications: Out of specification observed during the accelerated stability conditions for the 30 count bottles.
US
Eugia US LLC recalls Progesterone Injection USP, 500mg per 10 mL (50mg/mL), 10 mL Multiple Dose Vial, Rx Only, Mfd. in India for: Eugia US LLC. E. Windsor NJ…
Presence of Particulate Matter: A market complaint was received of a glass piece in the vial.
US