Prescription blood thinner recalled nationwide amid FDA warning

Alkem Laboratories Ltd. and Major Pharmaceuticals recalled three lots of dabigatran etexilate capsules, a generic blood thinner, nationwide in the United States on Wednesday. The Food and Drug Administration issued the recall due to concerns over product quality affecting 299,520 capsules distributed in various strengths and pack sizes, officials said.

The recall covers three specific lots of dabigatran etexilate capsules, a generic blood thinner that serves as an alternative to the brand-name drug Pradaxa. All three lots share an expiration date of April 30, 2027, and were distributed nationwide in the United States in a total of 5,460 cartons, containing 299,520 capsules, according to the Food and Drug Administration’s recall database.

The affected products include 150 mg capsules in 60-count blister packs, lot number 25141583; 75 mg capsules in 60-count blister packs, lot number 25141585; and 75 mg capsules in 30-count blister packs, lot number 25141586.

The capsules were manufactured by Alkem Laboratories Ltd., based in Mumbai, India, and distributed by Major Pharmaceuticals of Indianapolis. The recall was initiated voluntarily by Alkem Laboratories following stability testing that revealed the products failed to meet impurity and degradation specifications. Specifically, FDA testing found levels of Impurity II, Impurity III, and total impurities exceeding the acceptable limits for the medication, officials said. The FDA has not yet assigned a formal risk classification to this recall.

Dabigatran etexilate is prescribed to reduce the risk of stroke and blood clots, particularly in patients with nonvalvular atrial fibrillation. The drug is a direct oral anticoagulant and is widely used across the country. Records show that more than 5,000 prescriptions may have been affected by this recall. Medical experts caution that patients should not stop taking the medication abruptly, as sudden discontinuation of blood thinners can increase the risk of stroke or thrombotic events. Patients are advised to continue their therapy until consulting with a healthcare provider, according to FDA guidance and statements from health officials.

Pharmacies and distributors holding the recalled lots are expected to halt dispensing the product and follow instructions from the FDA and the manufacturers for returning or quarantining the affected inventory. Consumers who believe they have the recalled medication are urged to contact their pharmacist or healthcare provider for verification. The FDA’s MedWatch program provides a channel for reporting adverse events or quality concerns related to the recall.

This recall is distinct from a previous nationwide recall involving dabigatran etexilate capsules distributed by Ascend Laboratories. That earlier recall, which covered 10 lots with expiration dates in May and June 2024, was prompted by the presence of nitrosamine impurities such as NDMA and N-nitroso-dabigatran above FDA’s acceptable daily intake limits. The Ascend recall, announced in 2022, also involved 75 mg and 150 mg capsules but was unrelated to the current Alkem Laboratories recall. The FDA and consumer advocacy groups noted that long-term exposure to nitrosamines may increase cancer risk, but the agency advised patients to continue their medication until consulting a healthcare professional.

The current recall reflects ongoing monitoring of drug quality and manufacturing standards by the FDA. While no adverse clinical events have been documented in connection with the Alkem Laboratories lots, the agency’s action aims to prevent potential risks associated with impurity levels exceeding specifications. Media reports from outlets such as Yahoo News and AOL have detailed the recall, including the lot numbers, expiration dates, and company information, citing the FDA recall database.

The FDA continues to oversee the recall process and will update the public if additional information or risk classifications become available. Meanwhile, patients and healthcare providers are encouraged to maintain communication to ensure safe management of anticoagulation therapy.