The FDA has issued a nationwide recall for three specific lots of dabigatran (Pradaxa) capsules manufactured by Alkem Laboratories Ltd. and distributed by Major Pharmaceuticals after the lots failed impurity and degradation testing. Recalled strengths include 75 mg and 150 mg blister packs, all with expiration dates of April 30, 2027. Patients should check their packaging against the listed lot numbers and contact their pharmacist or healthcare provider if their medication is affected. Do not stop taking an anticoagulant without medical advice.
FDA Issues Nationwide Recall for Some Pradaxa (Dabigatran) Capsules — Check These Lot Numbers
FDA Recalls Prescription Blood Thinner NationwideMilko - Getty Images
If you or a loved one take an anticoagulant often called a "blood thinner," check your medicine cabinet: the U.S. Food and Drug Administration (FDA) has announced a nationwide recall of specific dabigatran (Pradaxa) capsules.
What Was Recalled?
The recall affects certain lots of dabigatran etexilate capsules manufactured by Alkem Laboratories Ltd. and distributed by Major Pharmaceuticals. The affected products reportedly failed impurity and degradation testing. The FDA has not yet assigned a formal risk level to the recall, so it remains unclear how likely the affected capsules are to cause adverse health effects.
Recalled Products
- Dabigatran Etexilate Capsules, 150 mg, 60-count blister pack
Lot number: 25141583
Expiration date: April 30, 2027 - Dabigatran Etexilate Capsules, 75 mg, 60-count blister pack
Lot number: 25141585
Expiration date: April 30, 2027 - Dabigatran Etexilate Capsules, 75 mg, 30-count blister pack
Lot number: 25141586
Expiration date: April 30, 2027
How to Check Your Medication
- Locate the blister pack and carton for your dabigatran (Pradaxa) capsules.
- Compare the lot number and expiration date on your packaging to the three lots listed above.
- If the lot number and expiration date match any listed lot, follow the steps below.
What To Do If You Have Recalled Capsules
Do not stop taking your anticoagulant without medical advice. Abruptly stopping an anticoagulant can increase the risk of blood clots and stroke. Instead:
- Contact your pharmacist or prescribing healthcare provider immediately for guidance and to arrange a replacement if needed.
- Keep taking your medicine until a clinician advises otherwise, unless you experience concerning symptoms.
- Document the lot number and expiration date (a photo can help) and retain the packaging until instructed to return or dispose of it.
- Report any adverse events or product problems to the FDA via MedWatch (the FDA's safety reporting program) and inform your healthcare provider.
Who Manufactured and Distributed the Product?
The recalled capsules were manufactured by Alkem Laboratories Ltd. and distributed by Major Pharmaceuticals. The FDA notice is the source of the recall information.
Final Notes
This recall applies only to the specific lot numbers and expiration dates listed above. If your medication does not match these details, it is not part of this recall. When in doubt, consult your pharmacist or healthcare provider for confirmation and safe next steps.
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