Telmisartan and Hyrdochlorothiazide Tablets 40mg/12 — Class II drug recall D-1003-2019
Terminated recall by Macleods Pharma Usa Inc, reported 2019-03-20, distributed nationwide. Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
| Recall number | D-1003-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharma Usa Inc, Plainsboro, NJ, United States |
| Recall initiated | 2019-02-25 |
| Classified | 2019-03-14 |
| Reported by FDA | 2019-03-20 |
| Terminated | 2021-07-12 |
| Distributed | Nationwide (US) |
| Quantity | 93,227 bottles |
| Reason classes | specification failure |
| NDC | 33342-0128-07 |
| Lot numbers | APR-19, APR-20, BTL703A, BTL705A, BTL706A, BTL707A, BTL708A, BTL709A, BTL710A, BTL711A, BTL801A, BTL802A, BTL803A, BTL804A, BTL805A, BTL807A, BTL807B, BTL809A, BTL810A, BTL811A, BTL812A, BTL813A, DEC-19, FEB-19, FEB-20, JUL-20, MAY-19, NOV-19, OCT-20, SEP-20 |
Product
Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07
Reason for recall
Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
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-1003-2019. 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.