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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

Aurobindo Pharma USA Inc.: Simvastatin 40mg Tablets Recalled Due to Incorrect Lot Number Labeling

Agency Publication Date: August 26, 2019
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Summary

Aurobindo Pharma USA Inc. is recalling 2,352 bottles of Simvastatin (simvastatin) 40 mg tablets because some 1,000-count bottles were printed with the incorrect lot number. Affected bottles are labeled with lot number 05318054B instead of the correct number, 05318034B. This medication, used to treat high cholesterol, was distributed nationwide to major distributors. If you have a bottle of this medication, you should verify the lot number on the label immediately.

Risk

Incorrect lot numbers on prescription medication labels can prevent healthcare providers and consumers from identifying products during safety events or quality concerns. While the medication itself is not defective, inaccurate labeling compromises the ability to track and manage the product's safety history.

What You Should Do

  1. Check your prescription bottle for Simvastatin Tablets, USP 40 mg (1000 count size) with NDC 65862-053-99 and lot number 05318054B with an expiration date of 3/2021.
  2. If your bottle matches these details, contact your healthcare provider or pharmacist for guidance on whether you should continue taking the medication or if you require a replacement.
  3. Return any unused product to the pharmacy where you purchased it for a refund.
  4. Contact Aurobindo Pharma USA Inc. at their East Windsor, NJ location for further instructions regarding this recall.
  5. For additional questions or to report a complaint, 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

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

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

Affected Products

Product: Simvastatin Tablets, USP 40 mg (1000 Count Bottles)
Model:
NDC 65862-053-99
Recall #: D-1842-2019
Lot Numbers:
05318054B (exp 3/2021)
Date Ranges: exp 3/2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83436
Status: Resolved
Manufacturer: Aurobindo Pharma USA Inc.
Sold By: major distributors
Manufactured In: United States
Units Affected: 2,352/1000 count bottles
Distributed To: Nationwide

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.