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Defective Digoxin Tablets Recalled

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A recall of digoxin tablets made by Caraco Pharmaceutical Laboratories was announced today.  Consumers are being warned that because of a manufacturing issue,  the tablets may differ in size and therefore could contain too much or too little of the drug’s active ingredient.

The recall applies to all tablets of Caraco brand Digoxin, USP, 0.125 mg, and Digoxin, USP, 0.25 mg, distributed prior to March 31, 2009, which are not expired and are within the expiration date of September, 2011.

Digoxin is a drug used to treat heart failure and abnormal heart rhythms. According to the Food & Drug Administration (FDA), a lower than labeled dose may pose a risk of lack of efficacy potentially resulting in cardiac instability. The existence of a higher than labeled dose may pose a risk of digoxin toxicity in patients with renal failure. Digoxin toxicity can cause nausea, vomiting, dizziness, low blood pressure, cardiac instability, and bradycardia. Death can also result from excessive digoxin intake.

The digoxin recall includes tablets with the following NDC codes:

Digoxin Tablets, USP, 0.125 mg
57664-437-88 (100-count)
57664-437-18 (1000-count)

Digoxin Tablets, USP, 0.25 mg
57664-441-88 (100-count)
57664-441-18 (1000-count)

Patients with these tablets should return them to their pharmacy or place of purchase.

Patients using Caraco’s digoxin tablets, USP, 0.125 mg or 0.25 mg, who have medical questions should contact their healthcare provider for additional instructions or guidance.

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