Reumofan Plus (Reumofan Plus USA) – Undeclared Ingredients (2013)
Class I: A situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death
Class I recall indicates potential for serious health consequences.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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.
Brand
Reumofan Plus USA
Lot Codes / Batch Numbers
Lot #: 99515, Exp 09/2016
Products Sold
Lot #: 99515, Exp 09/2016
Reumofan Plus USA is recalling Reumofan Plus, 30-count tablets per bottle, distriubted by Reumofan Plus USA, LLC and Reumofan USA, due to Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocar. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Marketed without an approved NDA/ANDA: Product may contain undeclared active pharmaceutical ingredients Diclofenac Sodium, Dexamethasone, and Methocarbamol.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026