The FDA recently announced a nationwide recall for specific lots of the prescription blood thinner dabigatran, also known by the brand name Pradaxa. This medication is widely prescribed to manage stroke risks and prevent blood clots in patients diagnosed with nonvalvular atrial fibrillation.
Alkem Laboratories Ltd. manufactured the affected capsules, and Major Pharmaceuticals distributed them. Internal testing identified issues related to impurity and degradation in the affected lots. At this time, the regulatory agency has not provided a specific risk assessment regarding potential side effects for those who took the impacted medication.
The recall covers 75-milligram and 150-milligram capsules distributed in blister packs within cartons. Consumers should verify their medication against the following lot numbers: 25141583 (150 mg, 60-count), 25141585 (75 mg, 60-count), and 25141586 (75 mg, 30-count). All these items carry an expiration date of April 30, 2027.
If you find your prescription matches these details, contact your pharmacist or physician immediately for guidance. Do not stop taking the medication on your own, as abrupt cessation of anticoagulants can trigger serious health complications. Speak with a healthcare professional to confirm if your supply is part of the recall and to arrange for a safe replacement.