Irbesartan Bulk Active Pharmaceutical Ingredient — Class II drug recall D-0127-2019
Terminated recall by Aurobindo Pharma Limited (Unit I), reported 2018-11-07, distributed in NY. CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingre
| Recall number | D-0127-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Aurobindo Pharma Limited (Unit I), Arutla, N/A, India |
| Recall initiated | 2018-10-24 |
| Classified | 2018-10-31 |
| Reported by FDA | 2018-11-07 |
| Terminated | 2020-03-27 |
| Distributed | NY |
| Quantity | 1,724.8 kilograms |
| Reason classes | chemical contamination, cgmp, specification failure |
| Lot numbers | 1601100782, 1601100783, 1601101589, 1601101590, 1701111861, 1701112056, 1701112170, 1701112501, 1701112558, 1701112559, 1701112589, 1701113300, 1701113301, 1701113302, 1701113312, 1701113404, 1701113405, 1701113406, 1701113407, 1701114283, 1701114285, 1701114286, 1701114289, 1701114291, 1701114708, 1701114709, 1701115460, 1701115738, 1701115739, 1701115740, 1701115741, 1701115742, 1701115974, 1701117039, 1701117040, 1701117041, 1701117042, 1701117043, 1701117044, 1701117045 and 1 more |
| Expiration dates | 2018-12-01, 2020-09-01, 2020-10-01, 2020-11-01 |
Product
Irbesartan Bulk Active Pharmaceutical Ingredient.
Reason for recall
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
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-0127-2019. 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.