Reumofan Plus tablets recalled for undeclared active pharmaceutical ingredients
Reumofan Plus tablets are being recalled because they were marketed without an approved NDA/ANDA and may contain undeclared active ingredients.
What this means for you
Highest-severity recall. Risk of serious injury or death is documented or strongly suspected. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which mandates a severity score of 5 according to the rubric.
Plain-English summary
Reumofan Plus USA, LLC and Reumofan USA, LLC are recalling 586 bottles of Reumofan Plus, 30-count tablets. The product was distributed nationwide through internet sales. The specific lot number is 99515, with an expiration date of 09/2016.
The recall was initiated because the product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA). Additionally, the product may contain undeclared active pharmaceutical ingredients, specifically Diclofenac Sodium, Dexamethasone, and Methocarbamol.
Consumers who have purchased this product should stop using it and contact the recalling firm for further instructions.
The recalled product
- Product
- Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, LLC, Springfield, PA, and manufactured by Riger Natural S.A., Mexico.
- Manufacturer
- Reumofan Plus USA
- Category
- Drug — Tablets
- Affected units
- 586
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #: 99515
- Exp 09/2016
Distribution
Distributed nationwide across the United States.
Related recalls
Same hazard · undeclared ingredients
See all →- CriticalFDA Recalls Addall XR Shot Liquid Dietary Supplement
FDA (Food) · 2026-09-02
- SevereD'Dioses Mango Ice Pops Recalled for Undeclared Allergens
FDA (Food) · 2026-07-22
- ModerateSuper ProTHIN Plus Dietary Supplement Recalled for Undeclared Dyes
FDA (Food) · 2025-07-02
- LowGaiser's Recalls Ready-to-Eat Bologna Due to Undeclared Meat Ingredients
USDA FSIS · 2025-06-27
- HighFlour tortillas recalled due to undeclared wheat allergen
FDA (Food) · 2024-05-29