Pioglitazone and Metformin Hydrochloride Tablets — Class III drug recall D-0838-2020
Terminated recall by Macleods Pharma Usa Inc, reported 2020-02-12, distributed nationwide. Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metfo
| Recall number | D-0838-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Macleods Pharma Usa Inc, Plainsboro, NJ, United States |
| Recall initiated | 2020-01-24 |
| Classified | 2020-02-11 |
| Reported by FDA | 2020-02-12 |
| Terminated | 2022-12-16 |
| Distributed | Nationwide (US) |
| Quantity | 4,694 |
| Reason classes | potency, specification failure |
| NDC | 33342-0176-09 |
| Lot numbers | BPA5819A, BPA5903A |
| Expiration dates | 2020-11, 2021-05 |
Product
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09
Reason for recall
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
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-0838-2020. 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.