The recall involves products distributed by Major Pharmaceuticals, manufactured by Alkem Laboratories in India, and recalled by Ascend Laboratories, LLC. According to the U.S. Food and Drug Administration (FDA), the recall remains ongoing and has not yet received a health hazard classification.
The affected medication is a generic version of Pradaxa, an anticoagulant prescribed to reduce the risk of stroke and blood clots in patients with conditions such as atrial fibrillation. While the generic product is subject to the recall, the source material states that brand-name Pradaxa is not known to be affected.
Stability testing identified impurity levels above approved specifications
According to the FDA notice, the voluntary recall was initiated after routine 12-month long-term stability testing produced out-of-specification results for related substances. Testing found elevated levels of Impurity II, Impurity III, and total impurities under long-term storage conditions of 25 ±2°C and 60 ±5% relative humidity.
The agency’s event report states that the affected products no longer met the approved degradation specifications before the end of their labeled shelf life. As medicines age, manufacturers routinely perform stability testing to confirm that degradation remains within established limits. In this case, the tested batches exceeded those limits.
The recall covers three specific products distributed within the U.S. market. These include Dabigatran Etexilate Capsules 150 mg in 60-count blister packs, lot number 25141583, with an expiration date of April 30, 2027; Dabigatran Etexilate Capsules 75 mg in 60-count blister packs, lot number 25141585, expiring April 30, 2027; and Dabigatran Etexilate Capsules 75 mg in 30-count blister packs, lot number 25141586, also expiring April 30, 2027.
According to the FDA event details, the withdrawal affects 3,600 cartons of the 150 mg product, 924 cartons of the 75 mg 60-count product, and 936 cartons of the 75 mg 30-count product, for a total of 5,460 cartons.
Patients are advised to verify lot numbers before taking action
The FDA states that the recall was initiated by Ascend Laboratories on July 16, 2026, through direct notification by letter. The event remains active, with no termination date listed and no press release issued by the recalling firm.
According to reports, patients who have dabigatran etexilate capsules should check the lot number printed on their prescription packaging, often located near the expiration date. If the lot number matches one of the recalled batches, patients are advised to contact their pharmacist or physician regarding a replacement.
The source also notes that patients should not stop taking a blood thinner on their own. Abruptly discontinuing anticoagulant therapy can present its own health risks, making it important to seek guidance from a healthcare professional before making any changes to treatment.
At the time of publication, the FDA had not assigned a classification describing the severity of the potential health risk associated with the recall. The agency lists the recall status as ongoing, with distribution limited to the U.S. market.
