The FDA has announced a nationwide recall affecting three specific lots of dabigatran etexilate, a common blood thinner. This decision follows failed dissolution specifications during routine stability testing. The agency classifies this as a Class III recall, indicating the medication is unlikely to cause adverse health consequences for users.
The affected products were distributed by Major Pharmaceuticals and sold in various strengths and counts. Specifically, the recall includes the 75-milligram 30-count pack with lot code 25141586, the 75-milligram 60-count pack with lot code 25141585, and the 150-milligram 60-count pack with lot code 25141583. All these products have an expiration date of April 30, 2027.
Patients should check their medication bottles immediately to see if their supply matches these specific lot codes. If you possess any of the recalled capsules, contact your local pharmacy to arrange for a refund or a replacement. The FDA notes that the medication would not maintain its expected stability through the 12-month window. If you have concerns about your prescription, reach out to your pharmacist or healthcare provider for guidance. For general inquiries regarding this action, the FDA can be reached at 1-888-INFO-FDA.