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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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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Macleods Pharma Usa Inc: Pioglitazone Hydrochloride Tablets Recalled for Being Superpotent

Agency Publication Date: October 11, 2019
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Summary

Macleods Pharma USA, Inc. has recalled approximately 31,968 bottles of Pioglitazone Hydrochloride (Actos) 15 mg tablets, a prescription medication used to manage blood sugar in adults with type 2 diabetes. The recall was issued because the tablets were found to be superpotent, meaning they contain more of the active ingredient than specified. Consumers should contact their healthcare provider or pharmacist immediately to discuss their treatment and how to return the affected medication.

Risk

Because these tablets are superpotent, they contain an excessively high dose of the medication which can cause blood sugar levels to drop dangerously low (hypoglycemia). This condition can lead to symptoms like dizziness, confusion, or loss of consciousness if not addressed.

What You Should Do

  1. Check your prescription bottle to see if you have Pioglitazone Hydrochloride Tablets USP 15 mg in 30-count bottles with NDC 33342-054-07.
  2. Verify the lot number and expiration date on the side of the bottle to see if it matches lot number BPF901A with an expiration date of 12/2021.
  3. Contact your healthcare provider or pharmacist immediately to report the use of this affected medication and to obtain a safe replacement supply.
  4. Return any unused tablets from the affected lot to your pharmacy for a refund and further instructions.
  5. For additional questions regarding this recall, contact Macleods Pharma USA, Inc. or call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA).

Your Remedy Options

๐Ÿ’ฐFull Refund

Healthcare consultation and refund

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

Affected Products

Product: Pioglitazone Hydrochloride Tablets USP 15 mg (30 count bottles)
Model:
NDC 33342-054-07
Recall #: D-0140-2020
Lot Numbers:
BPF901A (Exp 12/2021)
Date Ranges: 12/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83960
Status: Resolved
Manufacturer: Macleods Pharma Usa Inc
Sold By: Distributors
Manufactured In: India, United States
Units Affected: 31,968 bottles
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

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.