Telmisartan and Hyrdochlorothiazide Tablets — Class II drug recall D-1004-2019
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-1004-2019 |
|---|---|
| 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 | 140,589 bottles |
| Reason classes | specification failure |
| NDC | 33342-0129-07 |
| Lot numbers | APR-19, APR-20, BTM703A, BTM704A, BTM706A, BTM707A, BTM709A, BTM710A, BTM711A, BTM712A, BTM713A, BTM714A, BTM715A, BTM801A, BTM802A, BTM803A, BTM804A, BTM806A, BTM807A, BTM809A, BTM810A, BTM811A, BTM812A, BTM813A, BTM814A, BTM815A, BTM816A, BTM817A, BTM818A, BTM819A, DEC-19, FEB-19, JUL-20, JUN-19, MAR-20, NOV-19, NOV-20, OCT-19, SEP-20, TM708A |
Product
Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Imachal Pradesh, India NDC 33342-129-07
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-1004-2019. 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.