Perindopril Erbumine Tablets (Boehringer Ingelheim) – Impurity Risk (2012)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
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
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
Brand
Boehringer Ingelheim Roxane Inc
Lot Codes / Batch Numbers
Lot #160017A, Exp 04/2013.
Products Sold
Lot #160017A, Exp 04/2013.
Boehringer Ingelheim Roxane Inc is recalling Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Lab due to Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.. 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
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
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