Macleods Pharma Usa Inc recalls Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods
Macleods Pharma recalls 15mg/500mg Pioglitazone and Metformin tablets due to subpotent drug levels. These prescription pills may not contain enough active ingredients. Check your prescription bottles for lot numbers BPA5903A or BPA5819A.
Lower-risk recall
Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
Contact the company & request your remedy
What happened, in plain English
Macleods Pharma is recalling prescription Pioglitazone and Metformin tablets because lab tests showed they contain less active drug than specified. This means the pills might not work as intended for diabetes treatment. Read more at govinfonow.com/recall/37403-macleods-pioglitazone-and-metformin-tablets-recall-subpotent-drug-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/37403-macleods-pioglitazone-and-metformin-tablets-recall-subpotent-drug-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0838-2020
Cite this page
“Macleods Pioglitazone and Metformin Tablets Recall: Subpotent Drug Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/37403-macleods-pioglitazone-and-metformin-tablets-recall-subpotent-drug-risk. Based on FDA recall #D-0838-2020 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0838-2020%22&limit=1).
Why it’s dangerous
The tablets contain less active drug than required by lab tests. This means they might not effectively treat diabetes. However, the risk is not immediate harm but potential treatment failure if the pills don't work properly.
Who’s affected
Prescription diabetes patients who have the specific 60-count bottle with lot numbers BPA5903A (expiring May 2021) or BPA5819A (expiring November 2020). Patients using these pills for diabetes treatment are most at risk.
How to tell if you have this one
Check your prescription bottle for the brand 'Macleods', product name 'Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg', and lot numbers BPA5903A or BPA5819A. These were manufactured for specific expiration dates.
- Brand
Macleods- Category
Drug
What to do — step by step
Check Your Bottle
Look for lot numbers BPA5903A (expiring May 2021) or BPA5819A (expiring November 2020) on the prescription bottle.
Questions people ask
Why is this medication being recalled?
The tablets were found to have subpotent drug levels, meaning they contain less active ingredient than specified in lab tests.
What should I do if I have these tablets?
Check your bottle for the specific lot numbers mentioned. If you have the recalled lot numbers, contact your doctor or pharmacist for advice.
Are these tablets safe to use?
The tablets may not work as intended due to lower drug levels, but they are not unsafe to use. Patients should consult their doctor about alternative treatment options.
Contact Macleods
We’ve drafted a message you can send Macleods to request your refund or repair — edit it as you like.
Subject: Recall D-0838-2020 — Macleods Macleods Hello, I own a Macleods that is covered by recall D-0838-2020 from Macleods. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0838-2020 (January 24, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0838-2020 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.