Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg — Class II drug recall D-1005-2019
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-1005-2019 |
|---|---|
| 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 | 134,495 bottles |
| Reason classes | specification failure |
| NDC | 33342-0130-07 |
| Lot numbers | APR-20, AUG-20, BTN703A, BTN704A, BTN705A, BTN706A, BTN707A, BTN802A, BTN802B, BTN803A, BTN804A, BTN805A, BTN806A, BTN807A, BTN807B, BTN808A, BTN809A, BTN810A, BTN811A, BTN812A, BTN813A, BTN814A, DEC-19, FEB-19, FEB-20, JUN-19, JUN-20, MAY-19, SEP-20 |
Product
Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-130-07
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-1005-2019. 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.