Generic Digoxin Recall Issued Due to Oversized Tablets

Caraco Pharmaceutical Laboratories has issued a generic digoxin recall after discovering that some pills may have been distributed that contain more or less of the active drug than they should. A similar recall was issued last year due to oversized Digitek, a different brand of the generic heart drug digoxin, which has been linked to 667 deaths.

Digoxin is a medication used to treat abnormal heart rhythms, atrial flutter, atrial fibrillation and heart failure. It is derived from digitalis contained in foxglove plants and has been used for cardiac treatment since the 18th century. It is currently sold by a number of different generic drug makers.

Caraco issued the Digoxin recall for all lots of the drug they produced, including 0.125 mg tablets (which are round yellow tablets with an imprint of “437”) and 0.25 mg tablets (which are round white tablets with an imprint of “441”). The tablets were sold in 100-count and 1000-count bottles.

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According to a press release issued on March 31, 2009, the recall was issued because some of the tablets may differ in size and therefore could provide too much or too little of the medication.

Digoxin is a very dose-specific drug with a narrow therapeutic index and receiving more or less of the drug could pose a serious risk of injury.

Receiving less Digoxin than the doctor prescribed could cause the medication to be ineffective, potentially resulting in cardiac instability.

If too much of the drug is taken, it could cause digoxin toxicity, particularly among those suffering from renal failure. An overdose of digoxin could cause high levels of digitalis to build up inside the body, potentially resulting in life-threatening conditions, with symptoms like nausea, vomiting, low blood pressure, dizziness, bradycardia and cardiac instability.

In April 2008, Actavis Totowa issued a similar digoxin recall for their brand of the generic heart drug, Digitek, after it was discovered that oversized tablets were commercially released. According to a report issued by the Center for Public Integrity in December 2008, at least 667 digoxin deaths were reported to the FDA between April 2007 and June 2007 involving potentially double strength Digitek tablets.

Actavis Totowa and several of their distributors currently face a growing number of Digitek lawsuits filed on behalf of individuals who have suffered severe or fatal injuries caused by digoxin toxicity. All of the federal cases are consolidated in an MDL in the U.S. District Court for the Southern District of West Virginia before U.S. District Judge Joseph Goodwin, who is also coordinating the management of the litigation with various state court judges throughout the United States.

8 Comments

  • jenniferOctober 27, 2011 at 6:28 am

    my father passed away 2years ago, i need someone to tell me the generic and any other med that would be "called" this.

  • JuliAugust 11, 2009 at 11:11 pm

    My 18-year-old daughter died of multi-system failure due to Digtek's overdose pills. She suffered, unable to communicate or move for her 23 days in the hospital and the two weeks before when the family doctor sent her home instead of to the hospital, as sick as she was. Then, again, there is the pain she suffered, the endless medical procedures because none of her 13 doctors ran the test for Digox[Show More]My 18-year-old daughter died of multi-system failure due to Digtek's overdose pills. She suffered, unable to communicate or move for her 23 days in the hospital and the two weeks before when the family doctor sent her home instead of to the hospital, as sick as she was. Then, again, there is the pain she suffered, the endless medical procedures because none of her 13 doctors ran the test for Digoxin poisoning, even though she had all the symptoms and this is the first test that should be done in this case. It's been a year now, and I still see the images from the hospital at times. My heart is broken. My daughter died for greed.

  • Digoxin Drug Recall Issued by AS Medications Solutions - AboutLawsuits.comMay 13, 2009 at 3:09 pm

    [...] Caraco digoxin recall was issued on March 31, 2009, for all lots of 0.125 mg tablets (which are round and yellow with an [...]

  • JudyApril 30, 2009 at 7:43 pm

    My husband received the notice of the recall Thursday, April 9. He had been experiencing terrible and unusual issues for approximately 1 + months. The remaining pills were exchanged by the pharmacy. He died a sudden death on April 14. Something needs desperately to be done to publicize the issues that are obvious now.

  • DanielApril 23, 2009 at 5:40 pm

    Got this med from VA. ended up in the hosp.

  • LorettaApril 11, 2009 at 4:28 pm

    I have just returned the remainder of my perscription for Dioxin (55pills) and received a replacement because of malformation of the pills I have been taking. As I research this I cannot feel confident that what I am taking now is completely safe. Why are patients put in this position by our pharmaceutical laboratories!

  • Digoxin Recall Causes Other Generic Drug Makers to Step Up Supply - AboutLawsuits.comApril 3, 2009 at 8:34 pm

    [...] the nationwide recall of Digoxin manufactured by Caraco Pharmaceutical Laboratories due to potentially oversized and undersized [...]

  • RonApril 1, 2009 at 9:27 pm

    I think it's a shame that this company does not have controll over what they are sending out to door, to supply patiens with the wrong dose of meds. I'm just glad I am alive at this point.

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