FDA Drug recall D-1040-2019
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc…
- FDA Drug
- Class II
- terminated
- Published 2019-03-27
On 2019-03-27 the FDA classified a Class II recall of Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc… by Macleods Pharma Usa, citing CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1040-2019 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2019-02-21 |
| Published | 2019-03-27 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Macleods Pharma Usa |
| Distribution | FL, NJ, NY |
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
CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
Identifiers
| code_info | Lot BLM715A, Jul-19 |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1040-2019%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.