The FDA has recalled three lots of dabigatran etexilate capsules distributed nationwide after the products failed dissolution specifications during stability testing. The affected blister-pack lots from Major Pharmaceuticals include specific NDCs and lot codes, all expiring April 30, 2027. The recall is Class III — not likely to cause health consequences — and there is no evidence of contamination or incorrect active ingredient. Patients with matching lots should return the medication to their pharmacy and consult their healthcare provider before changing therapy.
FDA Announces Nationwide Recall of Three Dabigatran Etexilate Lots — Check Your Medication
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The U.S. Food and Drug Administration (FDA) has announced a nationwide recall of three lots of dabigatran etexilate capsules (the generic of Pradaxa) after stability testing showed the products failed required dissolution specifications.
What Was Recalled
The recalled products are blister-packaged dabigatran etexilate capsules distributed by Major Pharmaceuticals. The affected packs, including NDCs, lot codes, and expiration dates, are listed below:
- 75 mg — 30-count — NDC: 0904-7253-04; Lot: 25141586; Exp: April 30, 2027
- 75 mg — 60-count — NDC: 0904-7253-68; Lot: 25141585; Exp: April 30, 2027
- 150 mg — 60-count — NDC: 0904-7255-68; Lot: 25141583; Exp: April 30, 2027
Why the Recall Was Issued
Stability testing found these lots did not meet dissolution criteria over a 12-month window. Dissolution testing evaluates how quickly and completely a medication dissolves — a key factor for consistent dosing. There is no evidence the capsules were contaminated or that the active ingredient is incorrect.
Recall Classification and What It Means
The FDA classified this as a Class III recall, indicating the problem is not likely to cause adverse health consequences. However, because dabigatran is an anticoagulant used to reduce the risk of blood clots and stroke, patients should not stop or change therapy without medical advice.
What You Should Do
- Check your medication packaging for the NDC, lot number, and expiration date listed above.
- If your product matches any affected lot, return it to the dispensing pharmacy for a refund or replacement.
- Before making any changes to your dosing or stopping the medication, consult your pharmacist or healthcare provider to avoid increased clotting risk.
- For recall questions, contact the FDA at 1-888-INFO-FDA (1-888-463-6332).
Note: Dabigatran etexilate is a prescription anticoagulant; follow your clinician's guidance. If you experience unexpected bleeding, bruising, or other symptoms, seek medical attention.
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