CLASS II Drug recall · Reported 23 Oct 2019 · FDA Enforcement Report
Pioglitazone Hydrochloride Tablets USP 15 mg recalled
Macleods Pharma Usa is recalling Pioglitazone Hydrochloride Tablets USP 15 mg. The recall was initiated on 23 Sep 2019 and the FDA has classified it as Class II.
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-0140-2020
- FDA event ID
- 83960
- Recalling firm
- Macleods Pharma Usa, Plainsboro, NJ
- Brand
- Pioglitazone
- Manufacturer
- Macleods Pharmaceuticals Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Sep 2019
- FDA classified
- 11 Oct 2019
- Reported
- 23 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Diabetes Medication
Timeline
| 23 Sep 2019 | Recall initiated by company | |
| 11 Oct 2019 | Classified by FDA | +18 days |
| 23 Oct 2019 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent
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 Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India NDC 33342-054-07
Where it was distributed
Product was shipped to 8 distributors who may have further distributed the product.
Questions about this recall
Why was it recalled?
Superpotent
Which lots are affected?
Lot # BPF901A, exp. date 12/2021
Where was it sold?
Product was shipped to 8 distributors who may have further distributed the product.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 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 III | Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg recalled | Macleods Pharma Usa | Potency & Assay | Nationwide |
| 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 |