Losartan Potassium and Hydrochlorothiazide Tablets — Class II drug recall D-1040-2019
Terminated recall by Macleods Pharma Usa Inc, reported 2019-03-27, distributed in FL, NJ, NY. CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingre
| Recall number | D-1040-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharma Usa Inc, Plainsboro, NJ, United States |
| Recall initiated | 2019-02-21 |
| Classified | 2019-03-21 |
| Reported by FDA | 2019-03-27 |
| Terminated | 2020-09-28 |
| Distributed | FL, NJ, NY |
| Quantity | 9,695 bottles |
| Reason classes | chemical contamination, cgmp, specification failure |
| NDC | 33342-0052-10 |
| Lot numbers | BLM715A, JUL-19 |
Product
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-0052-10
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-1040-2019. 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.