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.
Read the official notice →- Date
- 2025-03-26
- Country
- United States
- Brand
- Rising Pharma Holding
- Product
- Duloxetine Delayed-Release Capsules, USP, 30 mg, 1,000-count bottle, Rx only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663,…
- Classification
- Class II
- Units
- Nationwide in the USA.
- 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 Details may be shortened or out of date; the official notice is the authoritative source.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
- 2026-07-29
US
Rising Pharma Holding, Inc. recalls Rising, Cyproheptadine Hydrochloride Syrup, 2mg/5 mL, 473 mL (ONE PINT), Rx only, Manufactured for: Rising Pharma Holdings, Inc.,…
Presence of Precipitate: medication was crystallizing and particles floating in the bottle
- 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…
- 2025-01-15
US
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.
- 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.
Other drugs & medical recalls in the United States
- 2025-03-26
US
One Source Nutrition, Inc, recalls Vitality, Fast Acting Male Enhancement Product, Dietary Supplement, a) One Capsule per Packet, b) 6 capsules per bottle, Xtreme…
Marketed without an approved NDA/ANDA: Product found to be tainted with undeclared sildenafil and tadalafil.
US
MYLAN PHARMACEUTICALS INC recalls Prasugrel Tablets, USP, 5 mg, 30-count bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC…
Failed Dissolution Specifications - low dissolution results
US
Slate Run Pharmaceuticals recalls Cinacalcet Hydrochloride Tablets 60 mg, 30-count bottle, Rx only, Distr. by: Slate Run Pharma., LLC, Columbus, Ohio 43215, Mfg. by:…
CGMP deviations: The presence of nitrosamine impurity above the acceptable daily intake limits.
FDA · DrugSlate Run PharmaceuticalsProduct was distributed to 8 distributors who may have further distribute the…Official notice →- 2025-03-20
US
Woolite Delicates Detergent Recalled by Reckitt Due to Risk of Exposure to Bacteria; Sold Exclusively on Amazon.com
The recalled products can contain Pseudomonas species bacteria, including Pseudomonas oleovorans, an environmental organism found widely in soil and water. People with weakened immune systems or external medical…
- 2025-03-19
US
Cordis US Corp recalls Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding catheter is intended for use for intravascular…
Catheter manufactured at the incorrect length.
US
Zimmer, Inc. recalls Z1 Femoral Hip System, Product Number 611777612
There is a potential design issue with the Z1 Offset Stem Inserter leading to fracturing of the distal tip.