Perindopril Erbumine Tablets — Class III drug recall D-126-2013
Terminated recall by Boehringer Ingelheim Roxane Inc, reported 2013-01-23, distributed nationwide. Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's m
| Recall number | D-126-2013 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Boehringer Ingelheim Roxane Inc, Columbus, OH, United States |
| Recall initiated | 2012-12-12 |
| Classified | 2013-01-16 |
| Reported by FDA | 2013-01-23 |
| Terminated | 2014-06-16 |
| Distributed | Nationwide (US) |
| Quantity | 3,553 bottles |
| Reason classes | specification failure |
| NDC | 00054-0112-25 |
| Lot numbers | 160017A |
| Expiration dates | 2013-04 |
Product
Perindopril Erbumine Tablets, 8mg, 100 Tablets per Bottle, Rx Only, Boehringer Ingelheim, Roxane Laboratories Inc., Columbus, OH 43216, NDC 0054-0112-25.
Reason for recall
Impurities/Degradation Products: Out of Specification results found for impurity B, identified as the drug's metabolite.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-126-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.