Pradaxa Capsules (Boehringer) – container damage (2012)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT --- NDC 0597-0149-54
Brand
Boehringer Ingelheim Roxane Inc
Lot Codes / Batch Numbers
Lot 201900 Expiration Date: JAN 2015
Products Sold
Lot 201900 Expiration Date: JAN 2015
Boehringer Ingelheim Roxane Inc is recalling Pradaxa (dabigatran etexilate), 75 mg Capsules, 60 count bottles, Rx only, Distributed by Boehringer due to Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Defective container; damaged bottles could allow moisture to get into the bottle and thus may impair the quality of the product
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026