The Recall Desk
HighFDA (Drugs)·D-0558-2024·Announced 2024-06-26

OSSOS-SANS tablets recalled: undeclared diclofenac and methocarbamol found

OSSOS-SANS Reforzado tablets are being recalled because they contain undeclared active pharmaceutical ingredients—diclofenac and methocarbamol—and were marketed without FDA approval.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving undeclared active pharmaceutical ingredients (diclofenac and methocarbamol). The source text does not report any illnesses or injuries. The hazard is serious—consumers expecting a dietary supplement are receiving unauthorized pharmaceutical drugs—but without reported harm, the score is 3 per the rubric.

Plain-English summary

OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets (packaged in 30-count bottles) are being recalled.

The product is manufactured by MexHealth LLC and distributed as 20 bottles nationwide. FDA laboratory testing found that the product contains two undeclared active pharmaceutical ingredients: diclofenac (a non-steroidal anti-inflammatory drug) and methocarbamol (a muscle relaxant). The product was marketed without an approved New Drug Application (NDA) or Abbreviated New Drug Application (ANDA).

Consumers who purchased OSSOS-SANS Reforzado tablets with Lot Number H29585 should stop using the product immediately. Consumers concerned about their health should contact their healthcare provider or poison control for guidance.

For questions, contact the FDA's Drug Safety and Availability Division at https://www.fda.gov/drugs/drug-safety-and-availability/drug-recalls or MexHealth LLC.

The recalled product

Product
OSSOS-SANS Reforzado con: Glucosamina Curcuma Ortiga tablets, packaged in a 30-count bottle, DISTRIBUIDOR POR: Naturistas Especializados, Alce Blanco 180-A Fracc. Industrial, Edo. de Mexico C.P. 53370
Manufacturer
MexHealth LLC
Hazard
  • undeclared-diclofenac
  • undeclared-methocarbamol
  • unapproved-nda

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 Number: H29585
  • No Expiration date

Distribution

Distributed nationwide across the United States.