UPDATE 1: Caraco Digoxin Recall

Digoxin Tablets USP 0.125 mg and Digoxin Tablets USP 0.25 mg Recalled

The following information has been provided by the FDA as an update May 12, 2009, on the Caraco Digoxin tablet recall.

Caraco Pharmaceutical Laboratories, Ltd., a generic pharmaceutical company, announced today that 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, are being voluntarily recalled to the consumer level. The tablets are being recalled because they may differ in size and therefore could have more or less of the active ingredient, digoxin. The recalled tablets were manufactured by Caraco Pharmaceutical Laboratories, Ltd. This recall is being conducted with the knowledge of the Food and Drug Administration.

Consumers with the products with the following NDC codes that are within expiration should return these products to their pharmacy or place of purchase.

Product Identification
Caraco Digoxin 0.125 mg is a scored round biconvex yellow tablet imprinted with "437"
Caraco Digoxin 0.25 mg is a scored round biconvex white tablet imprinted with "441"

NDC Numbers:

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 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.

Legal Help

If you or a loved one has suffered adverse health effects from consuming these medications, please click the link below and your complaint will be sent to a lawyer who may evaluate your claim at no cost or obligation.
Published on May-12-09