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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

Aurobindo Pioglitazone Tablets Recalled for Superpotency

Agency Publication Date: January 24, 2022
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Summary

Aurobindo Pharma USA Inc. is recalling 792 bottles of Pioglitazone (Pioglitazone Tablets USP), a medication used to treat type 2 diabetes. The recall was initiated because the tablets were found to be superpotent, meaning they contain more active medicine than intended, and failed to meet quality specifications. No incidents or injuries have been reported in connection with this recall to date. Affected products were distributed nationwide in 500-count bottles.

Risk

Taking medication that is superpotent can lead to a higher dose than prescribed, which increases the risk of serious side effects like hypoglycemia (dangerously low blood sugar), potentially leading to dizziness, confusion, or loss of consciousness.

What You Should Do

  1. The recalled product is Pioglitazone Tablets USP, 45 mg, sold in 500-count bottles under NDC 57237-221-05.
  2. Check your medication bottle for batch numbers PF4520028B or PF4520028A, and lot number PF4520028B, with an expiration date of 11/2022.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Aurobindo Pharma USA Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Pioglitazone Tablets USP (500-count bottle)
Variants: 45 mg, Tablet
Lot Numbers:
PF4520028B (Exp 11/2022)
PF4520028A (Exp 11/2022)
NDC:
57237-221-05

Recall #: D-0450-2022; Distributed by Aurobindo Pharma USA, Inc., East Windsor, NJ

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89323
Status: Resolved
Manufacturer: Aurobindo Pharma USA Inc.
Sold By: Authorized distributors; Retail pharmacies
Manufactured In: United States
Units Affected: 792 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.