Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Pradaxa (dabigatran etexilate) Recalled by Boehringer Ingelheim Roxane Inc Due to Defective container; damaged bottles could allow moisture to...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Boehringer Ingelheim Roxane Inc directly.
Affected Products
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
Quantity: 8,381 bottles
Why Was This Recalled?
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Boehringer Ingelheim Roxane Inc
Boehringer Ingelheim Roxane Inc has 15 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report