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Unrated Drug recall · FDA · Published December 29, 2021

Aurobindo Pharma Pioglitazone Tablets 45mg Recall: Superpotent Tablet Risk

Aurobindo Pharma recalls 45mg Pioglitazone tablets with failed specifications that may be superpotent. Consumers should check NDC 57237-221-05 and batch numbers PF4520028A/B for affected products.

🇺🇸 FDA recall #D-0450-2022DrugAurobindo Pharma ›
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Recalling firmAurobindo Pharma USA Inc.279 Princeton Hightstown Rd · East Windsor, NJ 08520-1401
✎ GovInfoNow plain-language explainer

What happened, in plain English

Aurobindo Pharma is recalling 45mg Pioglitazone tablets that may have failed specifications, making them superpotent. This could cause harmful effects if taken as directed. Read more at govinfonow.com/recall/35414-aurobindo-pharma-pioglitazone-tablets-45mg-recall-superpotent-tablet-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/35414-aurobindo-pharma-pioglitazone-tablets-45mg-recall-superpotent-tablet-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0450-2022

Cite this page

“Aurobindo Pharma Pioglitazone Tablets 45mg Recall: Superpotent Tablet Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35414-aurobindo-pharma-pioglitazone-tablets-45mg-recall-superpotent-tablet-risk. Based on FDA recall #D-0450-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0450-2022%22&limit=1).

Why it’s dangerous

The tablets may have failed specifications, meaning they could be superpotent. This could lead to harmful effects if taken as directed, potentially causing serious health issues.

Who’s affected

People who own or use the recalled 45mg Pioglitazone tablets with NDC 57237-221-05 and batch numbers PF4520028A or PF4520028B are affected. Those taking the medication for diabetes are most at risk.

How to tell if you have this one

Check for NDC 57237-221-05 on the product label. The batch numbers are PF4520028A or PF4520028B with an expiration date of November 2022.

  • Brand
    Aurobindo Pharma
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for NDC 57237-221-05 and batch numbers PF4520028A or PF4520028B on the tablet packaging.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 23 months after the firm started it.

1. Firm started the recall: Dec 29, 202112. FDA classified it Class II: Jan 24, 202223. Published in FDA’s Enforcement Report: Feb 2, 202234. FDA terminated the recall: Dec 4, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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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-0450-2022 (December 29, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0450-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA