FDA Drug recall D-0838-2020
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc
- FDA Drug
- Class III
- terminated
- Published 2020-02-12
On 2020-02-12 the FDA classified a Class III recall of Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc by Macleods Pharma Usa, citing subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0838-2020 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2020-01-24 |
| Published | 2020-02-12 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Macleods Pharma Usa |
| Distribution | US |
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
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Identifiers
| ndc | 33342-176-09 |
|---|---|
| ndc | 33342-176-11 |
| ndc | 33342-176-57 |
| ndc | 33342-176-44 |
| ndc | 33342-176-12 |
| ndc | 33342-177-09 |
| ndc | 33342-177-11 |
| ndc | 33342-177-57 |
| ndc | 33342-177-44 |
| ndc | 33342-177-12 |
| code_info | Lot# BPA5903A, EXP 05/2021; BPA5819A, EXP 11/2020 |
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-0838-2020%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.