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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Prescription Drugs

Macleods Pharma Usa Inc: Pioglitazone and Metformin Hydrochloride Tablets Recalled for Subpotency

Agency Publication Date: February 5, 2020
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Summary

Macleods Pharma USA Inc. is recalling 4,694 bottles of Pioglitazone and Metformin Hydrochloride Tablets (15 mg/500 mg), a prescription medication used to manage blood sugar in adults with type 2 diabetes. The recall was initiated because testing found the tablets were subpotent, meaning they contain less of the active medication than required by safety specifications. Using subpotent medication may result in higher blood sugar levels than intended, which can affect the management of diabetes. Consumers should contact their doctor or pharmacist immediately to discuss treatment alternatives.

Risk

The affected medication contains lower levels of active ingredients than specified, which can lead to ineffective treatment and Poor control of blood glucose levels for patients with type 2 diabetes.

What You Should Do

  1. Check your prescription bottle to see if it is Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg in a 60-count bottle.
  2. Identify if your bottle belongs to affected lot BPA5903A with an expiration date of 05/2021 or lot BPA5819A with an expiration date of 11/2020.
  3. If you have an affected bottle, contact your healthcare provider or pharmacist immediately for guidance on obtaining a replacement and do not stop taking your medication until you have a replacement and professional medical advice.
  4. Return any unused product from these specific lots to your pharmacy for a refund.
  5. Contact Macleods Pharma USA Inc. at their Plainsboro, New Jersey office for further instructions regarding this recall.
  6. For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and pharmacy return

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg (60-count bottle)
Model:
NDA 33342-176-09
Lot Numbers:
BPA5903A (Exp 05/2021)
BPA5819A (Exp 11/2020)
Date Ranges: Exp 05/2021, Exp 11/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84754
Status: Resolved
Manufacturer: Macleods Pharma Usa Inc
Sold By: pharmacies
Manufactured In: India, United States
Units Affected: 4694 30x60-count bottles
Distributed To: Nationwide
Agency Last Updated: February 11, 2020

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.