COMPANY STATEMENT
LABORATORIOS SOPHIA REPORTS UNAUTHORIZED SALES AND THE DETECTION OF SUSPECT COUNTERFEIT PRODUCTS IDENTIFIED AS MANZANILLA SOPHIA® IN THE UNITED STATES.
Zapopan, Jalisco, Mexico, October 2, 2026. – Laboratorios Sophia S.A. de C.V., in close coordination and ongoing communication with the U.S. Food and Drug Administration (FDA), is notifying its distributors in the United States of the detection of suspected counterfeit Manzanilla Sophia® (Sterile Chamomile Ophthalmic Solution, 15 mL) products that have been illegally introduced into the U.S. market.
Drug not approved in the United States: Manzanilla Sophia® is manufactured in Mexico and distributed exclusively in Latin American markets. The appearance of products labeled with the Manzanilla Sophia ® brand in the United States may involve counterfeit units or authentic product brought in through unauthorized channels. Laboratorios Sophia does not import, market, or distribute Manzanilla Sophia® in the United States and has not authorized any third parties to do so.
Health risk: The identified products suspected to be counterfeit do not come from Laboratorios Sophia’s authorized facilities. Because their origin, true composition, and the conditions under which they were manufactured, transported, or stored are unknown, the quality and sterility standards required for an ophthalmic solution cannot be assured. Using products suspected to be counterfeit or of unknown origin may pose health risks, including eye infection, vision loss, or other serious harm due to possible microbiological contamination. The safety and effectiveness of these counterfeit products cannot be guaranteed; therefore, they should not be used.
Request for cooperation from our distributors. To help protect consumer health and support ongoing investigative actions, Laboratorios Sophia respectfully asks its distributors in the United States to:
Notify the facilities and retail outlets in your network about the presence of suspected counterfeit Manzanilla Sophia® products.
Request photographs of any suspected counterfeit product found at commercial locations and share them with Laboratorios Sophia.
Obtain, whenever possible, samples of the suspected products for shipment to Laboratorios Sophia for potential analysis.
Provide the name and address of the establishments where suspected or allegedly counterfeit products have been identified.
Check with the establishment managers about the product’s origin, including any available information on suppliers, intermediaries, or supply channels.
Request immediate removal from shelves of any product identified as, or suspected of being, counterfeit, and inform the establishments that these products may pose a risk to patients.
Request that they precautionarily suspend sales and segregate the suspected units, avoiding its use, disposal, or return until instructions are received from Laboratorios Sophia or the appropriate authority.
We especially appreciate the support of our distributors in promptly identifying these products, limiting their circulation, and helping safeguard the well-being of consumers and patients.
Please refer to the images on how to identify the counterfeit product:
We strongly recommend carefully checking the product’s secondary packaging before any use. Our investigation has identified the following discrepancies in counterfeit units:
- Batch and Expiration Errors: Irregularities in the way expiration dates are printed, and batch/lot numbers that do not match legitimate manufacturing records (e.g., Lot 4027006).
- Packaging Defects: The shades in the center of the flower differ from our approved design. The registered trademark is positioned differently, and the text beneath the Sophia logo that reads “OTC Line” is also different.
Visual comparison between the authentic product and the allegedly counterfeit product.
Allegedly Counterfeit Product
Figure 1. Images received and reviewed by Laboratorios Sophia of the allegedly counterfeit.
Figure 2. Images received and reviewed by Laboratorios Sophia of the allegedly counterfeit product.
Figure 3. Images received and reviewed by Laboratorios Sophia of the allegedly counterfeit product.
Reference Images of Authentic Products (Mexico)
Figure 4. Authentic Manzanilla Sophia ® Product Marketed by Laboratorios Sophia
Reference images of authentic products (LATAM)
Figure 5. Authentic Manzanilla Sophia ® product marketed by Laboratorios Sophia
This notice applies solely to products identified as Manzanilla Sophia® that are found in, or offered for sale in, the United States. It does not affect or call into question the quality, safety, effectiveness, authenticity, or regulatory status of Manzanilla Sophia ® manufactured by Laboratorios Sophia and lawfully marketed through authorized channels in Mexico and in certain Latin American markets, in accordance with the applicable laws in each jurisdiction.
