Irbesartan and Hydrochlorothiazide Tablets USP — Class II drug recall D-0090-2022
Terminated recall by Lupin Pharmaceuticals Inc., reported 2021-11-10, distributed nationwide. CGMP Deviations: impurity N-nitrosoirbesartan detected in API
| Recall number | D-0090-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2021-10-12 |
| Classified | 2021-11-01 |
| Reported by FDA | 2021-11-10 |
| Terminated | 2023-01-30 |
| Distributed | Nationwide (US) |
| Quantity | 98,052 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 68180-0414-06, 68180-0414-09 |
| Lot numbers | 31/05/2022, H804082, H804121, H804192, H804338, H804538, H804539, H805348, H805349, H805350, H900065, H900066, H900067, H902264, H902265, H902275, H902276, H902531, H902532 |
Product
Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
Reason for recall
CGMP Deviations: impurity N-nitrosoirbesartan detected in API
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-0090-2022. 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.