Safety Alerts & Recalls

What does this mean?

Upsher-Smith has determined that the risk of serious injury in someone taking the recalled product is low and has only recalled these medicines at the warehouse and pharmacy level only. That said, if you are currently taking the Jantoven brand of warfarin tablets, you should check your current prescription as soon as possible and follow up with your pharmacist if your tablets do not look the same as what you usually receive. If you are experiencing excessive bleeding or bruising please seek medical attention right away. If you have any other questions or concerns about your medicine, please follow up with your doctor, pharmacist, or other healthcare professional. Since Jantoven is used to treat a serious condition, you should check with your healthcare provider before making any changes to your medicines.

Consumers and pharmacists can call the Upsher-Smith at 1-877-492-4791 for more information and to access product details, Monday-Friday between 8:00 a.m. and 5:00 p.m. (EST). Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of the recalled medicine to the FDA's MedWatch Adverse Event Reporting Program by telephone at 1-800-332-1088, by fax at 1-800-332-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at

Upsher-Smith Expands Recall of Jantoven to Include More Tablet Strengths and Other Products

Upsher-Smith Laboratories, Inc. is voluntarily expanding its previously announced recall of Jantoven Warfarin Sodium, USP, 3 mg Tablets to include Jantoven 1 mg, Jantoven 2 mg, Jantoven 2.5 mg, Jantoven 3 mg, Jantoven 4 mg, Jantoven 5 mg, Jantoven 6 mg, Jantoven 7.5 mg, and Jantoven 10 mg tablets and other medicines that were packaged on the same packaging line between May 17, 2010 and November 17, 2010. The company is initiating this expanded recall as a precautionary measure because a single bottle labeled as Jantoven Warfarin Sodium, USP, 3mg Tablets was found to contain tablets at a higher, 10mg strength before it was dispensed.

The substitution of a different warfarin strength, or any other product, may lead to a change in effectiveness or side effects from the medicines involved.

Warfarin is available as the generic name warfarin and brand names Coumadin and Jantoven. This expanded recall only involves select lots of Jantoven 1 mg, 2, mg, 2.5 mg 3 mg, 4 mg, 5 mg, 6 mg, 7.5 mg, and 10 mg tablets. No other brands of warfarin are involved in the recall.

For more information, please visit: more information here

Source: FDA
Publication Date: 2011-02-24
Last Updated: 2011-02-24

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