LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS — Class II drug recall D-0504-2019
Ongoing recall by Torrent Pharma Inc., reported 2019-02-27, distributed nationwide. CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API us
| Recall number | D-0504-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Torrent Pharma Inc., Kalamazoo, MI, United States |
| Recall initiated | 2018-12-20 |
| Classified | 2019-02-15 |
| Reported by FDA | 2019-02-27 |
| Distributed | Nationwide (US) |
| Quantity | 18,852 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 13668-0117-10, 13668-0117-90 |
| Lot numbers | BX35C020, BX35C022, BX35C023, BX35C049 |
| Expiration dates | 2019-05, 2019-08 |
Product
LOSARTAN POTASSIUM and HYDROCHLOROTHIAZIDE TABLETS, USP, 100 mg/12.5 mg, a) 90-count bottle (NDC: 13668-117-90), b) 1000-count bottle (NDC: 13668-117-10), Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana Inda
Reason for recall
CGMP Deviations: FDA lab confirmed presence an impurity, N-nitrosodimethylamine (NDEA) contained in the API used to manufacture the product above the interim acceptable daily intake level of 0.083 parts per million.
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-0504-2019. 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.