FDA is alerting consumers and health care professionals that counterfeit versions of Cialis 20 mg tablets were found in the mail on its way to a U.S. consumer. While this shipment was stopped, FDA is concerned about other possible mail shipments to consumers. FDA laboratory analysis showed the counterfeit versions contain multiple active ingredients, which if used could result in adverse effects or harm. Consumers should only buy prescription medicines from state-licensed pharmacies located in the U.S.
FDA cannot confirm that the manufacturing, quality, storage, and handling of these products follow U.S. standards because these products are from an unknown source. Therefore, these products are considered unsafe and should not be used.
FDA also recommends consumers talk to their health care professional about their condition and options for treatment if they received a counterfeit product.
FDA-approved Cialis tablets made by Eli Lilly contain the active ingredient, tadalafil, and are used for the treatment of erectile dysfunction and other approved indications. Currently, Eli Lilly’s authentic product is considered safe and effective for its intended uses. There is no indication that the legitimate supply chain is at risk, therefore consumers can be confident that prescription medicines received through legitimate state-licensed pharmacies located in the U.S. are safe and effective.
Counterfeit versions of Cialis can be identified by the following differences on the label of the bottle when compared to the authentic product. The label:
- lists “AUSTR81137” on the front of the bottle;
- does not include an NDC number on the front of the bottle, such as “NDC 0002-4462-30” for the 20 mg tablets;
- does not include the tablet strength in a colored box;
- has different patterns and colors; it has yellow and darker green designs on the front label;
- has misspellings; it lists, “CLALIS is a product of: Eli lilly Australia PTY Limited” on the side of the bottle;
- lists the manufacturer location as “112 Wharf Road, WEST RYDE, NSW 2114” on the side of the bottle; and
- lists “Lot: AC 066018, Exp: 01SEP17” on the side of the bottle.
Consumers should not use products that match one or more of the descriptions above. If you have additional information about these products, you may contact FDA at DrugSupplyChainIntegrity@fda.hhs.gov.
To date, FDA is not aware of consumer adverse events related to the use of these counterfeit versions of Cialis. Health care professionals and consumers are encouraged to report adverse events related to the use of any suspect medications to FDA’s MedWatch Adverse Event Reporting program by:
- Completing and submitting the report online at MedWatch Online Voluntary Reporting Form
- Downloading and completing the form (PDF - 1.22MB), then submitting it via fax at 1-800-FDA-0178
Consumers who buy prescription medicines online should be careful. Some websites sell medicine that may not be safe to use and may put their health at risk. Go to www.fda/gov/BeSafeRx for more information about the risks, to learn the signs of websites that may sell counterfeit or otherwise unsafe medicines, and how to find legitimate licensed online pharmacies.
FDA is committed to protecting public health by working to secure the drug supply chain against counterfeit and unapproved medications that enter the United States through fraudulent sources.
Picture of authentic bottle of Eli Lilly’s Cialis 20 mg Tablets sold in the U.S.