CLASS III Drug recall · Reported 12 Feb 2020 · FDA Enforcement Report
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg recalled
Macleods Pharma Usa is recalling Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, distributed nationwide in the US. The recall was initiated on 24 Jan 2020 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0838-2020
- FDA event ID
- 84754
- Recalling firm
- Macleods Pharma Usa, Plainsboro, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 24 Jan 2020
- FDA classified
- 11 Feb 2020
- Reported
- 12 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Diabetes Medication
Timeline
| 24 Jan 2020 | Recall initiated by company | |
| 11 Feb 2020 | Classified by FDA | +18 days |
| 12 Feb 2020 | Published in enforcement report | +1 day |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Which lots are affected?
Lot# BPA5903A, EXP 05/2021; BPA5819A, EXP 11/2020
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 30 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Macleods Pharma Usa
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets USP 150 mcg recalled by Macleods Pharma UsaLevothyroxine Sodium | Macleods Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma USA | Foreign Material | Nationwide |
| Drug | CLASS III | Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa | Macleods Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Eszopiclone Tablets, USP 1 mg recalled by Macleods Pharma UsaEszopiclone | Macleods Pharma Usa | Packaging Defects | Nationwide |
| Drug | CLASS II | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
Other Pioglitazone recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pioglitazone Tablets USP, 45 mg recalled by Aurobindo Pharma USAPioglitazone | Aurobindo Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Pioglitazone Hydrochloride Tablets USP 15 mg recalledPioglitazone | Macleods Pharma Usa | Potency & Assay | NJ |
| Drug | CLASS II | Pioglitazone and Glimepiride Tablets, USP, 30 mg/4 mg recalled by Sandoz | Sandoz | Potency & Assay | Nationwide |
| Drug | CLASS II | Pioglitazone, Tablet, 15 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Pioglitazone HCL, Tablet, 15 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |