Official recall notice
FDA DrugClass IIINotable
FDA Recall: Dabigatran etexilate Capsules, 110 mg, 60-count carton (6x10), Rx Only, Manufactured by: Alkem Labor
- Recall date
- 2026-07-29
- Category
- Drug
- FDA class
- Class III
Why it was recalled
Hazard
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Product description
Failed Impurities/Degradation Specifications: OOS result was observed during the related substance test analysis with respect to Impurity II, Impurity III and Total impurity testing for 12 Month Long-Term Stability.
Affected products
Lot: 25141707, Exp 4/30/2027.