A nationwide recall involving three lots of dabigatran etexilate capsules is affecting a prescription blood thinner distributed across the United States after testing found that the medication failed required dissolution specifications. Federal regulators have classified the action as a Class III recall, indicating that use of the affected products is unlikely to cause adverse health consequences, but patients are being advised to check their medication and contact their pharmacy if their supply is included.
FDA Recall Targets Dabigatran Etexilate Capsules
The U.S. Food and Drug Administration (FDA) reported that three lots of dabigatran etexilate capsules distributed and prescribed nationwide are subject to the recall. The affected medication was packaged in blister packs, distributed by Major Pharmaceuticals, and sold in different package sizes and strengths. According to the recall information cited by EatingWell, the action followed a failure to meet dissolution specifications during stability testing. Dissolution testing evaluates how a drug releases its active ingredient under defined conditions, making it part of the process used to assess whether a medication continues to perform according to its specifications over its intended shelf life.
In this case, the capsules did not demonstrate that they could meet the required specifications throughout a 12-month stability window. The issue therefore concerns the medication’s stability rather than evidence of contamination or the presence of an incorrect active ingredient. Patients taking dabigatran should check their packaging against the recall information, including the relevant NDC, lot code and expiration date, rather than assuming every supply of the medication is affected. The recall applies specifically to the identified lots.
Which Blood Thinners Are Being Recalled
The recall is limited to three specific lots of dabigatran etexilate capsules, rather than every prescription containing the drug. The affected capsules were packaged in blister packs and distributed by Major Pharmaceuticals. Patients should check the strength, package size, National Drug Code (NDC), lot code and expiration date printed on their medication. One affected product is the 75-milligram, 30-count package, carrying NDC 0904-7253-04 and lot code 25141586. The second is a 75-milligram, 60-count package, identified by NDC 0904-7253-68 and lot code 25141585. The third is the 150-milligram, 60-count package, with NDC 0904-7255-68 and lot code 25141583. All three recalled lots have the same expiration date: April 30, 2027. Matching the lot number and NDC is especially useful because the nationwide nature of the recall does not mean that every package of dabigatran etexilate in circulation is affected.
| Dabigatran Etexilate Capsule Packs | NDC | Lot Code | Expiration Date |
|---|---|---|---|
| 75-milligram, 30-count | 0904-7253-04 | 25141586 | April 30, 2027 |
| 75-milligram, 60-count | 0904-7253-68 | 25141585 | April 30, 2027 |
| 150-milligram, 60-count | 0904-7255-68 | 25141583 | April 30, 2027 |
Why The Recall Received A Class III Classification
The FDA categorized the action as a Class III recall, a designation used when exposure to or use of a product is not likely to cause adverse health consequences. That classification provides important context for patients who may see the words “blood thinner recall” and immediately assume that regulators have identified an acute safety emergency. According to the information accompanying the recall, there is no evidence that the capsules were contaminated, and there is no indication that the medication contained the wrong active ingredient.
The reason for the action is instead tied to the results of stability testing and the capsules’ inability to satisfy the applicable dissolution specifications over the expected stability period. This distinction does not make the recall irrelevant: prescription medicines are expected to remain within established specifications through their designated shelf life. It does mean that the FDA’s classification places the event in a lower-risk category than recalls involving products that could reasonably cause serious injury or death. Patients should therefore respond to the recall based on the specific instructions associated with their medication while avoiding assumptions that the classification signals an immediate medical emergency.
